RecruitingType 2 Diabetes
Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics
Eligible age
18–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
A randomized clinical study to assess the efficacy of a high-protein diabetes specific formula (HPDSF) on lean muscle mass in overweight and obese patients with type 2 diabetes who are initiating treatment with incretin-mimetic drugs.
Sponsor: Joslin Diabetes Center
You may qualify if…
- ✓ 1. Subject is between 18-75 years of age
- ✓ 2. Subject was diagnosed with type 2 diabetes at least 3 months prior to screening
- ✓ 3. Subject is about to start treatment with an IMD, a GLP-1 receptor agonist (RA) alone or a dual GLP-1/GIP RA. These treatments include either semaglutide (Ozempic®, Wegovy®), tirzepatide (Mounjaro®, Zepbound®), or dulaglutide (Trulicity®)
- ✓ 4. Body mass index (BMI) is ≥ 25 kg/m2
You may not qualify if…
- ✕ 1. Subject has type 1 diabetes mellitus
- ✕ 2. Subject with estimated glomerular filtration rate \<60 milliliters/minute/1.73 m²,
- ✕ 3. Urine albumin-to-creatinine ratio (UACR) of 300 mg/g or higher
- ✕ 4. History of acute kidney injury (AKI) during the 6 months prior to screening g.
- ✕ 5. Intolerance or allergy to HP-DSF shake or to any of its ingredients
- ✕ 6. Women who are pregnant or lactating or expect to be pregnant or lactating during the study period.
- ✕ 7. Women of childbearing potential who are not using highly effective contraceptive methods.
- ✕ \-
Where it's recruiting
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT07271043 · last updated 2026-05-29