What should be inclusion criteria for my irb described above
Asking for Preferences
Correlation of bmi whr and lipid profile in patients of type 2 dm is my dissertation topic What should be my inclusion criteria
Searching PubMed
BMI waist hip ratio lipid profile type 2 diabetes mellitus
Here are well-structured inclusion criteria for your IRB/dissertation protocol:
Inclusion Criteria
1. Confirmed Diagnosis of Type 2 Diabetes Mellitus
- Patients with a documented diagnosis of Type 2 DM as per ADA criteria (any one of):
- Fasting plasma glucose ≥ 126 mg/dL on two separate occasions
- HbA1c ≥ 6.5%
- 2-hour plasma glucose ≥ 200 mg/dL during OGTT
- Random plasma glucose ≥ 200 mg/dL with classic symptoms
2. Age
- Adults aged 18 to 65 years (or 30-65 years if you want to exclude very young-onset T2DM which may have different metabolic profiles)
3. Duration of Diabetes
- Known T2DM for at least 1 year (to ensure stable metabolic state and avoid newly diagnosed cases where lipid profile may not yet reflect the disease burden)
4. Willingness to Participate
- Patients willing to give written informed consent
5. Anthropometric Measurability
- Patients able to have BMI and WHR measured (i.e., ambulatory, not bedridden)
6. Availability of Lipid Profile
- Patients willing to undergo or having recent (within 3 months) fasting lipid profile (TC, TG, HDL-C, LDL-C, VLDL)
7. Either Gender
- Both male and female patients (as gender differences in fat distribution and lipids are a valid area of analysis)
Optional but Recommended Additions
| Criterion | Rationale |
|---|---|
| Outpatient/OPD-registered patients only | Ensures stable, non-acute metabolic state |
| On oral hypoglycemic agents (OHAs) only | Excludes insulin-dependent T2DM patients who may have more severe disease |
| Residents of the study area for ≥6 months | Controls for dietary/lifestyle confounders |
Tips for Your IRB Submission
- Keep the criteria specific but not overly restrictive - you need an adequate sample size
- Pair these with well-defined exclusion criteria (e.g., pregnancy, liver/kidney disease, thyroid disorders, statin use, Type 1 DM) which significantly affect lipid profiles
- Mention the diagnostic criteria source (ADA 2023 guidelines) explicitly in your protocol
Would you like me to draft the exclusion criteria as well, or help with sample size calculation for your study?
Should I include people on ohas
Yes, you should include patients on OHAs. Here's the reasoning:
Why Include OHA Users
1. Practical / Feasibility reason
- The vast majority of T2DM outpatients are on OHAs. Excluding them would make recruitment extremely difficult and your sample would be unrepresentative.
2. Scientific reason
- Your study is looking at correlation between anthropometric measures (BMI, WHR) and lipid profile - this relationship exists regardless of whether the patient is on OHAs.
- OHAs like metformin, sulfonylureas, DPP-4 inhibitors have minimal direct effect on lipid profile, so they don't significantly confound your outcome variable.
What You SHOULD Exclude (Drug-Related)
These drugs directly alter lipid profiles and ARE genuine confounders:
| Drug | Reason to Exclude |
|---|---|
| Statins / Fibrates / Niacin | Directly lower TC, LDL, TG - will mask true lipid levels |
| Insulin | Marks more severe/end-stage T2DM - different metabolic profile |
| Corticosteroids | Raise blood sugar AND alter lipids |
| Antipsychotics / atypicals | Cause dyslipidemia independently |
| Oral contraceptive pills (females) | Alter lipid fractions |
Practical Recommendation for Your Protocol
Write it as:
"Patients with Type 2 DM on diet control alone or on oral hypoglycemic agents (metformin, sulfonylureas, DPP-4 inhibitors, SGLT-2 inhibitors, or combinations thereof), not on insulin or lipid-lowering therapy."
One Caveat - SGLT-2 Inhibitors
Drugs like empagliflozin/dapagliflozin have a mild favorable effect on lipids (raise HDL slightly, lower TG). If you want a very clean study, you could note this as a limitation rather than excluding these patients, since excluding them further shrinks your pool.
Bottom line: Include OHA users, exclude insulin and lipid-lowering drug users. This gives you a large, representative, and scientifically valid study population.
Want help drafting the full exclusion criteria list now?
Ok thanks!
You're welcome! Best of luck with your dissertation. 😊
When you're ready, I can also help you with:
- Exclusion criteria
- Sample size calculation
- Methodology / study design
- Statistical analysis plan (which correlation tests to use for BMI, WHR vs lipid parameters)
- Review of similar published studies for your literature review
Just ask anytime!
This is a shared conversation. Sign in to Orris to start your own chat.