Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT07270068
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosed diabetes for a duration of \< 3 years (diagnosis based on 2 recorded diagnostic-level tests, HbA1C and/or blood glucose)
2. Body mass index (BMI) \> 25 kg/m2
3. HbA1C level above \> 6.5% to 9% as per the last routine clinical check within 6 months
4. Currently being treated with one or more oral glucose lowering drugs
Exclusion Criteria:
1. Type 1 DM
2. Type 2 DM on basal or multiple insulin injections
3. Recent routine HbA1C of \> 9%
4. Patients who in the past 6 months have weight loss exceeding 5 kg (such individuals may have difficulty losing additional weight)
5. Recent (last 12 weeks) or current use of medications/meal replacements for weight loss
6. Alcoholism or any substance abuse
7. History of bariatric surgery, small bowel resection, or extensive bowel resection
8. Chronic treatment with systemic corticosteroids. Use of hormone replacement therapy or oral contraceptives will not lead to exclusion
9. Severe hypertension on multiple drugs treatment
10. Currently pregnant or nursing and planning to get pregnant
11. Requiring hospitalization for depression or are on antipsychotic medications
12. Cancer requiring treatment for the past 5 years, except of non-melanoma skin cancers or cancers that have been clearly cured
13. HIV- positive (self-report) due to effects or weight and body composition of HIV and medications treating HIV
14. Cardiovascular disease (heart attack or procedure within past 3 months or participation in cardiac rehabilitation program within last 3 months, stroke or history/ treatment for transient ischemic attacks in the past 3 months, or documented history of pulmonary embolus for the past 6 months)
15. Renal disease - eGFR \< 60 ml/min (based MDRD) or currently receiving dialysis
16. Proliferative retinopathy and other severe diabetes complications
17. Diagnosed eating disorder or purging
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07270068
Study Brief:
Protocol Section:
NCT07270068