RecruitingNot Applicable

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

United States60 participantsStarted 2026-01-01

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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 Protality Base or Ensure Max Protein 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.

What they're measuring

Change in lean muscle mass from baseline

Timeframe: Endpoints will be analyzed at three months and six months.

Trial details

NCT IDNCT07271043

SponsorJoslin Diabetes Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-01

Contact for this trial

Jaime Jacob, BS

617-309-4152 jjacob4@joslin.harvard.edu

View on ClinicalTrials.gov More Type 2 Diabetes trials