Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics

Recruiting now · Not applicable

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT07271043

Run by

Joslin Diabetes Center

People needed

60

Starts

2026-01-01

Expected to finish

2026-12-01

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is between 18-75 years of age
• Subject was diagnosed with type 2 diabetes at least 3 months prior to screening
• 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®)
• Body mass index (BMI) is ≥ 25 kg/m2

You may not qualify if…

• Subject has type 1 diabetes mellitus
• Subject with estimated glomerular filtration rate <60 milliliters/minute/1.73 m²,
• Urine albumin-to-creatinine ratio (UACR) of 300 mg/g or higher
• History of acute kidney injury (AKI) during the 6 months prior to screening g.
• Intolerance or allergy to HP-DSF shake or to any of its ingredients
• Women who are pregnant or lactating or expect to be pregnant or lactating during the study period.
• Women of childbearing potential who are not using highly effective contraceptive methods.

Where it is running

• Joslin Diabetes Center — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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