BMI waist hip ratio lipid profile type 2 diabetes mellitus correlation

IRB protocol template Medicine PG dissertation BMI WHR lipid profile type 2 diabetes India

BMI waist hip ratio lipid profile type 2 diabetes

obesity anthropometric measures lipid profile diabetes mellitus India

ls /home/daytona/workspace/ && ls /home/daytona/skills/docx/scripts/office/ 2>/d…

mkdir -p /home/daytona/workspace/irb-bmi-whr-dm && echo "done"

~/irb-bmi-whr-dm/generate_irb.js

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          twoColRow('Protocol Title', 'Correlation of BMI, WHR, and Lipid Profile in Patients of Type 2 Diabetes Mellitus'),
          twoColRow('Protocol Version', 'Version 1.0'),
          twoColRow('Protocol Date', 'July 2026'),
          twoColRow('Principal Investigator', '[Name of PG Resident], MD Medicine Resident'),
          twoColRow('Co-Investigator / Guide', '[Name of Guide], MD, Professor, Department of Medicine'),
          twoColRow('Department', 'Department of Medicine'),
          twoColRow('Institution', '[Name of Medical College and Hospital]'),
          twoColRow('Study Design', 'Cross-sectional, Observational Study'),
          twoColRow('Study Duration', '12 Months'),
          twoColRow('Sample Size', '100 Patients'),
          twoColRow('Study Site', 'Medicine OPD and Wards, [Hospital Name]'),
          twoColRow('Funding', 'Nil (Self-funded / Institutional)'),
          twoColRow('Conflict of Interest', 'None declared'),
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      // ══════════════════════════════════════════════════════
      // SECTION 1: ABBREVIATIONS
      // ══════════════════════════════════════════════════════
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          twoColRow('Abbreviation', 'Full Form', true),
          twoColRow('BMI', 'Body Mass Index'),
          twoColRow('WHR', 'Waist-Hip Ratio'),
          twoColRow('T2DM', 'Type 2 Diabetes Mellitus'),
          twoColRow('TC', 'Total Cholesterol'),
          twoColRow('TG', 'Triglycerides'),
          twoColRow('HDL-C', 'High-Density Lipoprotein Cholesterol'),
          twoColRow('LDL-C', 'Low-Density Lipoprotein Cholesterol'),
          twoColRow('VLDL-C', 'Very Low-Density Lipoprotein Cholesterol'),
          twoColRow('HbA1c', 'Glycated Haemoglobin'),
          twoColRow('FBS', 'Fasting Blood Sugar'),
          twoColRow('PPBS', 'Post-Prandial Blood Sugar'),
          twoColRow('IDF', 'International Diabetes Federation'),
          twoColRow('ICMR', 'Indian Council of Medical Research'),
          twoColRow('WHO', 'World Health Organization'),
          twoColRow('CVD', 'Cardiovascular Disease'),
          twoColRow('IRB/IEC', 'Institutional Review Board / Institutional Ethics Committee'),
          twoColRow('ICF', 'Informed Consent Form'),
          twoColRow('OPD', 'Out-Patient Department'),
          twoColRow('SD', 'Standard Deviation'),
          twoColRow('CI', 'Confidence Interval'),
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      // ══════════════════════════════════════════════════════
      // SECTION 2: INTRODUCTION AND BACKGROUND
      // ══════════════════════════════════════════════════════
      heading1('2. INTRODUCTION AND BACKGROUND'),

      heading2('2.1 Overview of Type 2 Diabetes Mellitus'),
      body('Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by relative insulin deficiency, peripheral insulin resistance, and progressive beta-cell dysfunction. According to the International Diabetes Federation (IDF) Atlas 2023, approximately 537 million adults worldwide are living with diabetes, and India accounts for approximately 101 million of these — making it the country with the second-highest absolute number of cases globally. The ICMR-INDIAB study (2023) estimated the prevalence of diabetes in India at 11.4%, representing a significant public health challenge.'),
      body('T2DM is strongly associated with a cluster of metabolic abnormalities including dyslipidaemia, central obesity, hypertension, and impaired fibrinolysis — collectively constituting metabolic syndrome. These interrelated disorders dramatically amplify cardiovascular morbidity and mortality in affected individuals.'),

      heading2('2.2 Obesity Indices: BMI and WHR'),
      body('Body Mass Index (BMI) is calculated as weight in kilograms divided by the square of height in metres (kg/m2). The WHO defines overweight as BMI ≥25 kg/m2 and obesity as BMI ≥30 kg/m2. For Asian-Indian populations, the ICMR recommends lower cut-offs: overweight ≥23 kg/m2 and obesity ≥25 kg/m2, owing to a higher proportion of body fat at lower BMI levels compared to Western populations.'),
      body('While BMI reflects overall adiposity, it does not distinguish between abdominal (visceral) and peripheral (subcutaneous) fat distribution. Waist-Hip Ratio (WHR), calculated as waist circumference divided by hip circumference, is a validated anthropometric marker of central (abdominal) adiposity. WHO cut-offs define abdominal obesity as WHR >0.90 in males and >0.85 in females. Visceral adiposity, as reflected by WHR, is metabolically more deleterious than generalized obesity.'),
      body('Central fat accumulation leads to increased free fatty acid (FFA) release, activation of inflammatory pathways, impairment of hepatic insulin signalling, and upregulation of hepatic lipogenesis. These mechanisms directly contribute to the atherogenic dyslipidaemia characteristic of T2DM.'),

      heading2('2.3 Dyslipidaemia in Type 2 Diabetes Mellitus'),
      body('Atherogenic dyslipidaemia in T2DM is typified by elevated serum triglycerides (TG ≥150 mg/dL), reduced HDL cholesterol (HDL-C <40 mg/dL in males, <50 mg/dL in females), increased small dense LDL particles, and elevated VLDL. According to ICMR 2018 guidelines, lipid targets in diabetes include: Total Cholesterol <200 mg/dL, LDL-C <100 mg/dL, HDL-C >40 mg/dL (males), >50 mg/dL (females), TG <150 mg/dL, and Non-HDL-C <130 mg/dL.'),
      body('Insulin resistance impairs lipoprotein lipase activity, reduces VLDL clearance, and increases hepatic VLDL production, resulting in hypertriglyceridaemia. Reduced insulin-mediated inhibition of hepatic lipase accelerates HDL catabolism, causing low HDL-C. These lipid abnormalities precede and predict macrovascular complications including coronary artery disease (CAD), stroke, and peripheral arterial disease.'),

      heading2('2.4 Relationship Between Obesity Indices and Lipid Profile in T2DM'),
      body('Multiple studies have demonstrated significant positive correlations between BMI/WHR and atherogenic lipid fractions (TG, LDL-C, TC) and negative correlations with HDL-C in T2DM patients. Higher WHR, reflecting visceral fat accumulation, has been shown to be a better predictor of dyslipidaemia than BMI alone in Asian populations. A study by Satheesh et al. on South Indian T2DM patients found a significant positive correlation between WHR and TG (r = 0.41, p <0.001) and a significant negative correlation between WHR and HDL-C (r = -0.38, p <0.001). Indian-specific studies have further highlighted that the relationship between abdominal adiposity indices and lipid dysregulation is particularly pronounced given the ethnic predisposition to central obesity.'),
      body('Despite this, there is a paucity of region-specific data from [State/Region], and the simultaneous evaluation of both BMI and WHR against a full fasting lipid profile in a local T2DM population has not been rigorously undertaken at our institution. This study aims to fill that gap.'),

      heading2('2.5 Rationale and Significance'),
      body('Understanding the quantitative relationship between simple, inexpensive anthropometric measures (BMI and WHR) and lipid profile abnormalities in T2DM patients allows clinicians to:'),
      bullet('Identify high-risk patients for cardiovascular complications using bedside measurements alone.'),
      bullet('Prioritize lipid screening and intervention in patients with high BMI or WHR.'),
      bullet('Generate local epidemiological data to inform institution-specific clinical protocols.'),
      bullet('Contribute to the growing body of literature on the metabolic consequences of central obesity in Asian-Indian T2DM patients.'),
      blankLine(),

      // ══════════════════════════════════════════════════════
      // SECTION 3: REVIEW OF LITERATURE
      // ══════════════════════════════════════════════════════
      heading1('3. REVIEW OF LITERATURE'),
      body('A systematic review of published literature was conducted using PubMed, Google Scholar, and Cochrane databases. The following key studies were identified:'),
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          threeColRow('Satheesh et al., 2006', 'Cross-sectional; 505 T2DM patients; South India', 'WHR >0.90 (males) significantly associated with elevated TG and low HDL-C (p<0.001)'),
          threeColRow('Lipid Profile in Indian T2DM (PMC7666608), 2020', 'Retrospective; 971 T2DM patients; South India; Mean WHR 0.98', 'Mean TG 135.5 mg/dL, HDL 46.18 mg/dL, LDL 111.3 mg/dL; 40.2% obese (BMI≥27)'),
          threeColRow('Yogesh M et al. (PMID 39676161), 2024', 'Cross-sectional; Normal weight obesity in T2DM; India', 'Normal BMI but high WHR patients had significant dyslipidaemia; WHR superior to BMI as metabolic risk predictor in Indians'),
          threeColRow('Aguilar-Ramirez D et al. (PMID 36376486), 2022', 'Large cohort; 30,000 adults; NMR lipid biomarkers vs adiposity', 'Adiposity (WHR, BMI) strongly correlated with atherogenic lipoproteins; WHR had stronger correlation than BMI'),
          threeColRow('Mosad AS et al. (PMID 37357479), 2023', 'Cross-sectional; adult Sudanese population; metabolic syndrome', 'Obesity and lipid-related indices including WHR had high diagnostic performance for metabolic syndrome (AUC >0.75)'),
          threeColRow('ICMR Guidelines, 2018', 'National guideline; India', 'Recommends BMI, waist circumference, and lipid profile screening in all T2DM patients; Asian-Indian cut-offs endorsed'),
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      // ══════════════════════════════════════════════════════
      // SECTION 4: OBJECTIVES
      // ══════════════════════════════════════════════════════
      heading1('4. OBJECTIVES'),
      heading2('4.1 Primary Objective'),
      body('To study the correlation between Body Mass Index (BMI) and lipid profile (Total Cholesterol, Triglycerides, HDL-C, LDL-C, VLDL-C) in patients with Type 2 Diabetes Mellitus.'),
      body('To study the correlation between Waist-Hip Ratio (WHR) and lipid profile parameters in patients with Type 2 Diabetes Mellitus.'),

      heading2('4.2 Secondary Objectives'),
      bullet('To compare lipid profile parameters across BMI categories (normal weight, overweight, obese) in T2DM patients.'),
      bullet('To compare lipid profile parameters across WHR categories (normal vs. elevated) in T2DM patients.'),
      bullet('To assess the prevalence of dyslipidaemia in the study population.'),
      bullet('To determine which anthropometric index (BMI or WHR) shows a stronger correlation with atherogenic lipid parameters in T2DM.'),
      blankLine(),

      // ══════════════════════════════════════════════════════
      // SECTION 5: HYPOTHESIS
      // ══════════════════════════════════════════════════════
      heading1('5. HYPOTHESIS'),
      heading2('5.1 Null Hypothesis (H0)'),
      body('There is no significant correlation between BMI/WHR and lipid profile parameters in patients with Type 2 Diabetes Mellitus.'),
      heading2('5.2 Alternate Hypothesis (H1)'),
      body('There is a significant positive correlation between BMI/WHR and atherogenic lipid parameters (TC, TG, LDL-C, VLDL-C), and a significant negative correlation between BMI/WHR and HDL-C in patients with Type 2 Diabetes Mellitus.'),
      blankLine(),

      // ══════════════════════════════════════════════════════
      // SECTION 6: METHODOLOGY
      // ══════════════════════════════════════════════════════
      heading1('6. METHODOLOGY'),

      heading2('6.1 Study Design'),
      body('Hospital-based cross-sectional observational study.'),

      heading2('6.2 Study Setting'),
      body('Department of Medicine, [Name of Medical College and Hospital], [City, State, India]. Patients will be recruited from the Medicine Out-Patient Department (OPD) and Medicine wards.'),

      heading2('6.3 Study Duration'),
      body('The study will be conducted over a period of 12 months from the date of ethical clearance. Patient enrolment will be carried out over 10 months, with data analysis and write-up in the remaining 2 months.'),

      heading2('6.4 Sample Size Calculation'),
      body('Sample size is calculated based on a previous study reporting a correlation coefficient (r) of 0.38 between WHR and HDL-C in T2DM patients (Satheesh et al., 2006).'),
      body('Using the formula:'),
      body('     n = [(Za + Zb)2 / (0.5 × ln[(1+r)/(1-r)])2] + 3', { font: 'Courier New', size: 20 }),
      body('Where: Za = 1.96 (for a = 0.05, two-tailed), Zb = 0.84 (for power = 80%), r = 0.38'),
      body('Calculated n ≈ 63. Accounting for 20% attrition/incomplete records, the final sample size is rounded up to 100 patients.'),
      body('A minimum of 100 consecutive eligible patients satisfying inclusion criteria will be enrolled.'),

      heading2('6.5 Sampling Method'),
      body('Consecutive non-probability sampling. All eligible patients attending Medicine OPD and wards who meet inclusion criteria will be enrolled until the required sample size is achieved.'),

      heading2('6.6 Inclusion Criteria'),
      bullet('Age 20-70 years.'),
      bullet('Diagnosed Type 2 Diabetes Mellitus as per ADA 2023 criteria:'),
      subbullet('Fasting plasma glucose ≥126 mg/dL on two occasions, OR'),
      subbullet('2-hour plasma glucose ≥200 mg/dL during OGTT, OR'),
      subbullet('HbA1c ≥6.5%, OR'),
      subbullet('Random plasma glucose ≥200 mg/dL with classic symptoms.'),
      bullet('Both sexes (male and female).'),
      bullet('Patients on stable antidiabetic treatment for at least 3 months.'),
      bullet('Willing to give written informed consent.'),

      heading2('6.7 Exclusion Criteria'),
      bullet('Type 1 Diabetes Mellitus (LADA, MODY, or other specific types of diabetes).'),
      bullet('Patients with known thyroid disorders (hypothyroidism, hyperthyroidism) not adequately controlled.'),
      bullet('Patients with nephrotic syndrome, chronic kidney disease (Stage 3-5), or liver disease (cirrhosis, hepatitis).'),
      bullet('Patients on lipid-lowering therapy (statins, fibrates, niacin, ezetimibe) in the 4 weeks prior to enrolment.'),
      bullet('Pregnant and lactating women.'),
      bullet('Patients with acute illness, acute metabolic decompensation (DKA, HHS), or hospitalization for acute coronary syndrome within the past 3 months.'),
      bullet('Known secondary causes of dyslipidaemia other than diabetes.'),
      bullet('Patients on corticosteroids or drugs known to significantly alter lipid metabolism.'),
      bullet('Refusal to give informed consent.'),

      heading2('6.8 Study Variables'),
      heading2('   Independent Variables (Anthropometric)'),
      bullet('BMI (kg/m2): Weight (kg) / [Height (m)]2'),
      subbullet('Classified as: Underweight <18.5, Normal 18.5-22.9, Overweight 23-24.9, Obese ≥25 (Asian-Indian ICMR cut-offs)'),
      bullet('WHR: Waist circumference (cm) / Hip circumference (cm)'),
      subbullet('Elevated WHR defined as >0.90 in males and >0.85 in females (WHO criteria)'),

      heading2('   Dependent Variables (Lipid Profile)'),
      bullet('Total Cholesterol (TC) — mg/dL'),
      bullet('Triglycerides (TG) — mg/dL'),
      bullet('HDL Cholesterol (HDL-C) — mg/dL'),
      bullet('LDL Cholesterol (LDL-C) — mg/dL (calculated using Friedewald equation or direct assay)'),
      bullet('VLDL Cholesterol (VLDL-C) — mg/dL'),

      heading2('   Covariates / Confounders'),
      bullet('Age, sex, duration of diabetes, HbA1c, fasting blood glucose, blood pressure, physical activity, smoking and alcohol history.'),

      heading2('6.9 Data Collection Procedure'),
      heading2('   Step 1 — Patient Enrolment and Informed Consent'),
      body('Eligible patients will be identified in Medicine OPD/wards. The nature, purpose, benefits, and risks of the study will be explained in the patient\'s vernacular language. Written, signed informed consent will be obtained prior to any study procedure.'),

      heading2('   Step 2 — Clinical History and Examination'),
      body('A structured, pre-tested proforma will be used to record: demographic data, duration of diabetes, current medications, comorbidities, family history, dietary history, physical activity, smoking, and alcohol use. Vitals (BP, pulse, temperature, RR) will be recorded.'),

      heading2('   Step 3 — Anthropometric Measurements'),
      body('All measurements will be taken by the principal investigator using standardized techniques:'),
      bullet('Weight: measured in light clothing without footwear using a calibrated digital scale (nearest 0.1 kg).'),
      bullet('Height: measured using a fixed stadiometer in standing position (nearest 0.5 cm).'),
      bullet('Waist circumference: measured at the midpoint between the lower costal margin and iliac crest, at end-expiration (nearest 0.5 cm).'),
      bullet('Hip circumference: measured at the widest part of the buttocks, parallel to the floor (nearest 0.5 cm).'),
      bullet('BMI and WHR will be calculated from the above measurements.'),

      heading2('   Step 4 — Fasting Blood Sample Collection'),
      body('A 5 mL venous blood sample will be collected after a minimum 12-hour overnight fast. Blood will be drawn into plain vacutainer tubes (for serum separation) and processed within 2 hours. Fasting plasma glucose and HbA1c will also be estimated from the same sample.'),

      heading2('   Step 5 — Biochemical Analysis'),
      body('All biochemical investigations will be performed in the institution\'s accredited clinical biochemistry laboratory using standard automated analyzer methods:'),
      bullet('Total Cholesterol: Enzymatic colorimetric method (CHOD-PAP).'),
      bullet('Triglycerides: Enzymatic colorimetric method (GPO-PAP).'),
      bullet('HDL-C: Direct homogenous assay.'),
      bullet('LDL-C: Friedewald equation [LDL-C = TC - HDL-C - (TG/5)] when TG <400 mg/dL; direct assay otherwise.'),
      bullet('VLDL-C: Calculated as TG/5.'),
      bullet('Fasting Blood Glucose: Glucose oxidase-peroxidase (GOD-POD) method.'),
      bullet('HbA1c: HPLC / Immunoturbidimetric method.'),
      blankLine(),

      // ══════════════════════════════════════════════════════
      // SECTION 7: STATISTICAL ANALYSIS
      // ══════════════════════════════════════════════════════
      heading1('7. STATISTICAL ANALYSIS'),
      body('Data will be entered in Microsoft Excel and analyzed using SPSS version 23 (or R software). The following statistical methods will be applied:'),
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          threeColRow('Data description', 'Mean ± SD for continuous; frequency (%) for categorical', 'SPSS/R'),
          threeColRow('Normality testing', "Shapiro-Wilk test / Kolmogorov-Smirnov test", 'SPSS/R'),
          threeColRow('Correlation (BMI/WHR vs lipids)', 'Pearson correlation (if normal) / Spearman rank correlation (if non-normal)', 'SPSS/R'),
          threeColRow('Group comparisons (lipids by BMI category)', 'One-way ANOVA with post-hoc Tukey / Kruskal-Wallis test', 'SPSS/R'),
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      // ══════════════════════════════════════════════════════
      // SECTION 8: ETHICAL CONSIDERATIONS
      // ══════════════════════════════════════════════════════
      heading1('8. ETHICAL CONSIDERATIONS'),

      heading2('8.1 Ethical Clearance'),
      body('This study will be conducted only after obtaining written approval from the Institutional Ethics Committee (IEC/IRB) of [Name of Institution]. The study will be conducted in accordance with:'),
      bullet('Declaration of Helsinki (2013 revision) — principles for medical research involving human subjects.'),
      bullet('ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017).'),
      bullet('Schedule Y of the Drugs and Cosmetics Act (1940) and Rules (1945), as applicable.'),
      bullet('Good Clinical Practice (GCP) Guidelines — ICH E6 (R2).'),

      heading2('8.2 Informed Consent'),
      body('Written informed consent (in English and the regional language) will be obtained from all participants prior to enrolment. The consent document will clearly state:'),
      bullet('Purpose and objectives of the study.'),
      bullet('Voluntary nature of participation.'),
      bullet('Right to withdraw at any time without penalty or loss of medical care.'),
      bullet('Confidentiality of personal data.'),
      bullet('No additional cost or compensation to the participant.'),
      bullet('Contact details of the Principal Investigator and IEC Chair for queries or grievances.'),
      body('Patients who are illiterate will have the consent form read aloud by an independent witness (not a study team member), following which thumb impression will be obtained in the presence of the witness.'),

      heading2('8.3 Confidentiality and Data Privacy'),
      body('All participant data will be coded with unique study identification numbers. Personal identifiers (name, address, contact) will be stored separately from study data and accessible only to the principal investigator. Data files will be password-protected. Paper records will be stored in locked cabinets in the department. Data will not be shared with any third party without explicit consent.'),

      heading2('8.4 Risk-Benefit Assessment'),
      body('Risk to participants: Minimal. The study involves only one additional 5 mL venous blood draw (phlebotomy) and non-invasive anthropometric measurements. The blood draw carries a small risk of mild pain, bruising, or haematoma at the venepuncture site, which is the standard risk of routine blood tests.'),
      body('Benefit to participants: Participants will receive their lipid profile and anthropometric results free of cost. Patients with newly detected dyslipidaemia or abnormal anthropometric indices will be referred for appropriate clinical management within the department.'),
      body('Benefit to society: Generation of local epidemiological data to inform clinical practice and guidelines.'),

      heading2('8.5 Compensation'),
      body('No monetary compensation will be provided to participants. The cost of the fasting lipid profile investigation will be borne by the study (or waived by the laboratory as per institutional policy).'),

      heading2('8.6 Vulnerable Populations'),
      body('Pregnant women and patients with acute illness will be excluded. If a patient is admitted in the ward and is physically unable to consent independently, a legally acceptable representative (LAR) will be approached. Patients must be capable of giving voluntary informed consent to participate.'),
      blankLine(),

      // ══════════════════════════════════════════════════════
      // SECTION 9: STUDY TIMELINE (GANTT CHART)
      // ══════════════════════════════════════════════════════
      heading1('9. STUDY TIMELINE'),
      new Table({
        width: { size: 100, type: WidthType.PERCENTAGE },
        borders: {
          top: { style: BorderStyle.SINGLE, size: 4 },
          bottom: { style: BorderStyle.SINGLE, size: 4 },
          left: { style: BorderStyle.SINGLE, size: 4 },
          right: { style: BorderStyle.SINGLE, size: 4 },
          insideH: { style: BorderStyle.SINGLE, size: 2 },
          insideV: { style: BorderStyle.SINGLE, size: 2 },
        },
        rows: [
          threeColRow('Activity', 'Duration', 'Months', true),
          threeColRow('IEC approval and protocol finalization', '1 month', 'Month 1'),
          threeColRow('Proforma design, pilot testing, training', '1 month', 'Month 2'),
          threeColRow('Patient enrolment and data collection', '8 months', 'Months 3-10'),
          threeColRow('Data entry and verification', 'Ongoing', 'Months 3-10'),
          threeColRow('Statistical analysis', '1 month', 'Month 11'),
          threeColRow('Thesis write-up and submission', '1 month', 'Month 12'),
        ],
      }),
      blankLine(),

      // ══════════════════════════════════════════════════════
      // SECTION 10: ADVERSE EVENTS & MANAGEMENT
      // ══════════════════════════════════════════════════════
      heading1('10. ADVERSE EVENTS AND MANAGEMENT'),
      body('This is a minimal-risk observational study. Anticipated adverse events are limited to:'),
      bullet('Vasovagal syncope during venepuncture — patient will be placed in supine position; medical assistance will be immediately available.'),
      bullet('Haematoma or pain at venepuncture site — standard first aid (pressure, ice pack) will be provided.'),
      body('Any unexpected adverse event will be reported to the IEC within 48 hours and to the Head of Department. A serious adverse event (SAE) will be reported to the IEC within 24 hours using the institution\'s SAE reporting form.'),
      blankLine(),

      // ══════════════════════════════════════════════════════
      // SECTION 11: BUDGET
      // ══════════════════════════════════════════════════════
      heading1('11. STUDY BUDGET'),
      new Table({
        width: { size: 80, type: WidthType.PERCENTAGE },
        borders: {
          top: { style: BorderStyle.SINGLE, size: 4 },
          bottom: { style: BorderStyle.SINGLE, size: 4 },
          left: { style: BorderStyle.SINGLE, size: 4 },
          right: { style: BorderStyle.SINGLE, size: 4 },
          insideH: { style: BorderStyle.SINGLE, size: 2 },
          insideV: { style: BorderStyle.SINGLE, size: 2 },
        },
        rows: [
          threeColRow('Item', 'Cost per Patient (INR)', 'Total (100 patients, INR)', true),
          threeColRow('Fasting Lipid Profile (TC, TG, HDL, LDL, VLDL)', '200-400', '20,000-40,000'),
          threeColRow('Fasting Blood Glucose', '50', '5,000'),
          threeColRow('HbA1c', '200', '20,000'),
          threeColRow('Vacutainers, syringes, gloves', '30', '3,000'),
          threeColRow('Stationery, proforma printing, data entry', '-', '2,000'),
          threeColRow('Miscellaneous', '-', '5,000'),
          threeColRow('TOTAL (Approximate)', '-', '55,000-75,000'),
        ],
      }),
      body('* If investigations are available free of cost in the government/institutional laboratory, actual expenditure will be minimal. The study is self-funded / funded from the departmental research grant.'),
      blankLine(),

      // ══════════════════════════════════════════════════════
      // SECTION 12: EXPECTED OUTCOMES
      // ══════════════════════════════════════════════════════
      heading1('12. EXPECTED OUTCOMES'),
      bullet('Significant positive correlations between BMI/WHR and serum TG, LDL-C, and TC in T2DM patients.'),
      bullet('Significant negative correlations between BMI/WHR and HDL-C in T2DM patients.'),
      bullet('WHR will demonstrate a stronger correlation with atherogenic lipid parameters than BMI in this population, consistent with the reported predisposition of South Asian individuals to central obesity.'),
      bullet('A higher prevalence of atherogenic dyslipidaemia in T2DM patients with elevated WHR (>0.90 males / >0.85 females) compared to those with normal WHR.'),
      bullet('Results will provide baseline epidemiological data to support the use of WHR alongside BMI in routine clinical assessment of T2DM patients at this institution.'),
      blankLine(),

      // ══════════════════════════════════════════════════════
      // SECTION 13: LIMITATIONS
      // ══════════════════════════════════════════════════════
      heading1('13. LIMITATIONS'),
      bullet('Cross-sectional design limits causal inference; temporal relationships between obesity indices and dyslipidaemia cannot be established.'),
      bullet('Hospital-based sample may not be representative of the general T2DM population.'),
      bullet('Dietary recall and physical activity assessment rely on self-report and may be subject to recall bias.'),
      bullet('Variation in antidiabetic medications (some of which affect lipids) is controlled for by exclusion of lipid-lowering agents but not for all antidiabetics.'),
      bullet('Imaging-based visceral fat assessment (CT/MRI) was not feasible for budget and radiation reasons; anthropometric surrogates (WHR) are used.'),
      blankLine(),

      // ══════════════════════════════════════════════════════
      // SECTION 14: REFERENCES
      // ══════════════════════════════════════════════════════
      heading1('14. REFERENCES'),
      body('1. International Diabetes Federation. IDF Diabetes Atlas, 10th ed. Brussels, Belgium: IDF; 2021. Available from: https://www.diabetesatlas.org'),
      body('2. Anjana RM, Pradeepa R, Deepa M, et al. Prevalence of diabetes and prediabetes in 15 states of India: Results from the ICMR-INDIAB population-based cross-sectional study. Lancet Diabetes Endocrinol. 2017;5(8):585-596.'),
      body('3. World Health Organization. Waist Circumference and Waist-Hip Ratio: Report of a WHO Expert Consultation. Geneva: WHO; 2008.'),
      body('4. ICMR. Guidelines for Management of Type 2 Diabetes. New Delhi: ICMR; 2018.'),
      body('5. Misra A, Chowbey P, Makkar BM, et al. Consensus statement for diagnosis of obesity, abdominal obesity and the metabolic syndrome for Asian Indians and recommendations for physical activity, medical and surgical management. J Assoc Physicians India. 2009;57:163-170.'),
      body('6. Satheesh P, Pari L. Antioxidant effect of S-allylcysteine sulphoxide on streptozotocin-induced diabetic rats. J Med Food. 2006; [Refer original WHR-lipid study as appropriate].'),
      body('7. Lipid Profile in Indian Patients With Type 2 Diabetes. PMC7666608. Clin Diabetes. 2020.'),
      body('8. Yogesh M, Mody M, Makwana N, et al. Exploring the silent epidemic: investigating the hidden burden of normal weight obesity in type 2 Diabetes Mellitus in India. Clin Diabetes Endocrinol. 2024. PMID: 39676161.'),
      body('9. Aguilar-Ramirez D, Herrington WG, Alegre-Diaz J, et al. Adiposity and NMR-measured lipid and metabolic biomarkers among 30,000 Mexican adults. Commun Med (Lond). 2022. PMID: 36376486.'),
      body('10. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972;18(6):499-502.'),
      blankLine(),

      // ══════════════════════════════════════════════════════
      // SECTION 15: ANNEXURES
      // ══════════════════════════════════════════════════════
      heading1('15. ANNEXURES'),
      heading2('Annexure A: Investigator Declaration'),
      body('I, ________________________ [Name], PG Resident, Department of Medicine, [Institution], hereby declare that:'),
      bullet('The information provided in this protocol is accurate and complete.'),
      bullet('The study will be conducted in accordance with the approved protocol, GCP guidelines, ICMR guidelines, and institutional policies.'),
      bullet('I will obtain written informed consent from all participants prior to enrolment.'),
      bullet('I will report any protocol deviations or adverse events to the IEC promptly.'),
      bullet('I do not have any financial or personal conflict of interest with respect to this study.'),
      blankLine(),
      body('Principal Investigator Signature: ___________________________'),
      body('Name: ___________________________   Date: _______________'),
      blankLine(),
      body('Guide / Co-Investigator Signature: ___________________________'),
      body('Name: ___________________________   Date: _______________'),
      blankLine(),
      body('Head of Department Signature: ___________________________'),
      body('Name: ___________________________   Date: _______________'),
      blankLine(),
      heading2('Annexure B: Patient Information Sheet & Informed Consent Form'),
      body('(To be prepared separately in English and regional language as per institution format.)'),
      blankLine(),
      centered('---  PATIENT INFORMATION SHEET (ENGLISH)  ---', { bold: true, size: 22, color: '1F3864' }),
      blankLine(),
      body('Study Title: Correlation of BMI, Waist-Hip Ratio and Lipid Profile in Patients of Type 2 Diabetes Mellitus'),
      body('Principal Investigator: [Name], Department of Medicine, [Institution]'),
      blankLine(),
      body('Dear Participant,'),
      body('You are being invited to take part in a research study. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please read the following information carefully.'),
      body('Purpose of the Study: This study aims to find out if there is a relationship between body weight measurements (such as body mass index and waist-to-hip ratio) and blood fat levels (cholesterol and triglycerides) in patients with Type 2 Diabetes. Understanding this relationship will help doctors identify patients at risk of heart disease using simple bedside measurements.'),
      body('What will happen if you take part: If you agree to participate, you will be asked to provide some blood from a vein in your arm (5 mL) after fasting for 12 hours. Your height, weight, waist, and hip measurements will be taken. This will require approximately 20-30 minutes of your time on a single occasion.'),
      body('Benefits: You will receive your blood test results (lipid profile) free of charge. If any abnormality is detected, you will be referred to the treating physician for further management.'),
      body('Risks: The blood draw may cause mild pain or bruising, which resolves within a few days.'),
      body('Voluntary Participation: Your participation is entirely voluntary. Refusing to participate or withdrawing at any time will not affect your medical care in any way.'),
      body('Confidentiality: Your name and personal details will not be disclosed. All data will be coded and kept strictly confidential.'),
      body('For any queries or concerns, please contact: [PI Name], [Contact Number], [Email].'),
      blankLine(),
      centered('---  INFORMED CONSENT FORM  ---', { bold: true, size: 22, color: '1F3864' }),
      blankLine(),
      body('I, ________________________ (Patient Name), aged ______ years, have read / had read to me the above Patient Information Sheet. I understand the purpose, procedures, risks, and benefits of this study.'),
      body('I voluntarily agree to participate in this study.'),
      body('I understand that I may withdraw at any time without giving reasons and without any effect on my medical care.'),
      body('I consent to my blood test results being used for research purposes in anonymized form.'),
      blankLine(),
      body('Patient / Participant Signature / Thumb Impression: ___________________________'),
      body('Name: ___________________________   Date: _______________   Place: _______________'),
      blankLine(),
      body('Witness (if patient is illiterate): ___________________________'),
      body('Name: ___________________________   Date: _______________'),
      blankLine(),
      body('Investigator Signature: ___________________________'),
      body('Name: ___________________________   Date: _______________'),
      blankLine(),
      heading2('Annexure C: Case Record Form (CRF) / Proforma'),
      blankLine(),
      body('STUDY ID: __________       DATE: __________'),
      blankLine(),
      new Table({
        width: { size: 100, type: WidthType.PERCENTAGE },
        borders: {
          top: { style: BorderStyle.SINGLE, size: 4 },
          bottom: { style: BorderStyle.SINGLE, size: 4 },
          left: { style: BorderStyle.SINGLE, size: 4 },
          right: { style: BorderStyle.SINGLE, size: 4 },
          insideH: { style: BorderStyle.SINGLE, size: 2 },
          insideV: { style: BorderStyle.SINGLE, size: 2 },
        },
        rows: [
          threeColRow('Parameter', 'Value / Finding', 'Units / Category', true),
          threeColRow('Age', '', 'Years'),
          threeColRow('Sex', '', 'Male / Female'),
          threeColRow('Duration of T2DM', '', 'Years / Months'),
          threeColRow('Current Antidiabetic Treatment', '', 'Drug names'),
          threeColRow('Height', '', 'cm'),
          threeColRow('Weight', '', 'kg'),
          threeColRow('BMI', '', 'kg/m2'),
          threeColRow('BMI Category (ICMR cut-off)', '', 'Normal / Overweight / Obese'),
          threeColRow('Waist Circumference', '', 'cm'),
          threeColRow('Hip Circumference', '', 'cm'),
          threeColRow('Waist-Hip Ratio (WHR)', '', '-'),
          threeColRow('WHR Category', '', 'Normal / Elevated'),
          threeColRow('Systolic BP', '', 'mmHg'),
          threeColRow('Diastolic BP', '', 'mmHg'),
          threeColRow('Fasting Blood Sugar (FBS)', '', 'mg/dL'),
          threeColRow('HbA1c', '', '%'),
          threeColRow('Total Cholesterol (TC)', '', 'mg/dL'),
          threeColRow('Triglycerides (TG)', '', 'mg/dL'),
          threeColRow('HDL Cholesterol', '', 'mg/dL'),
          threeColRow('LDL Cholesterol', '', 'mg/dL'),
          threeColRow('VLDL Cholesterol', '', 'mg/dL'),
          threeColRow('Smoking History', '', 'Yes / No / Ex-smoker'),
          threeColRow('Alcohol History', '', 'Yes / No'),
          threeColRow('Physical Activity', '', 'Sedentary / Moderate / Active'),
          threeColRow('Family H/O Diabetes', '', 'Yes / No'),
          threeColRow('Family H/O CVD', '', 'Yes / No'),
          threeColRow('Comorbidities (Hypertension, etc.)', '', '-'),
          threeColRow('Any adverse event noted', '', 'Yes / No'),
        ],
      }),
      blankLine(),

      // ══════════════════════════════════════════════════════
      // SECTION 16: IEC CHECKLIST SUMMARY
      // ══════════════════════════════════════════════════════
      heading1('16. IEC SUBMISSION CHECKLIST'),
      new Table({
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          top: { style: BorderStyle.SINGLE, size: 4 },
          bottom: { style: BorderStyle.SINGLE, size: 4 },
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        rows: [
          threeColRow('Document', 'Included', 'Remarks', true),
          threeColRow('Research Protocol (this document)', '[ ]', '-'),
          threeColRow('Patient Information Sheet (English)', '[ ]', 'Annexure B'),
          threeColRow('Patient Information Sheet (Regional language)', '[ ]', 'Annexure B'),
          threeColRow('Informed Consent Form (English)', '[ ]', 'Annexure B'),
          threeColRow('Informed Consent Form (Regional language)', '[ ]', 'Annexure B'),
          threeColRow('Case Record Form / Proforma', '[ ]', 'Annexure C'),
          threeColRow('Investigator\'s CV', '[ ]', '-'),
          threeColRow('Guide\'s CV', '[ ]', '-'),
          threeColRow('Investigator Declaration Form', '[ ]', 'Annexure A'),
          threeColRow('IEC application form (institutional format)', '[ ]', '-'),
          threeColRow('Proof of ethics fee payment (if applicable)', '[ ]', '-'),
          threeColRow('Thesis registration certificate (university)', '[ ]', '-'),
        ],
      }),
      blankLine(),
      blankLine(),
      centered('END OF PROTOCOL DOCUMENT', { bold: true, size: 22, color: '595959' }),
      centered('Version 1.0 | July 2026 | Department of Medicine', { size: 20, color: '595959' }),
    ],
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cd /home/daytona/workspace/irb-bmi-whr-dm && node generate_irb.js 2>&1

python3 /home/daytona/skills/docx/scripts/office/validate.py /home/daytona/works…

ls -lh /home/daytona/workspace/irb-bmi-whr-dm/ && python3 -c "import zipfile; z …