High-protein diabetes formula to protect muscle in people with Type 2 diabetes starting incretin medications

Evaluating the Efficacy of High-Protein Diabetes Specific Formula (HP-DSF) on Body Composition in Overweight/Obese Patients With Type 2 Diabetes Treated With Incretin Mimetic Drugs

This study will test whether a high-protein diabetes-specific formula helps preserve or increase lean muscle in overweight or obese adults with type 2 diabetes who are starting GLP‑1 or dual GLP‑1/GIP incretin medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Joslin Diabetes Center (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07271043 on ClinicalTrials.gov

What this trial studies

This randomized clinical trial will give a high-protein diabetes-specific formula to overweight or obese adults with type 2 diabetes who are beginning treatment with GLP‑1 receptor agonists or dual GLP‑1/GIP receptor agonists and compare outcomes to a control group. Participants will be adults aged 18–75 with BMI ≥25 kg/m2 and diabetes diagnosed at least three months prior. The main outcome is change in body composition with a focus on lean muscle mass during initiation of semaglutide, tirzepatide, or dulaglutide therapy. The study is led by Joslin Diabetes Center with industry collaboration and requires in-person visits for measurements.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with type 2 diabetes for at least three months, BMI ≥25 kg/m2, adequate kidney function, and who are about to start a GLP‑1 or dual GLP‑1/GIP receptor agonist such as semaglutide, tirzepatide, or dulaglutide.

Not a fit: People with type 1 diabetes, significant kidney impairment (eGFR <60 mL/min/1.73 m2), very high albuminuria (UACR ≥300 mg/g), recent acute kidney injury, known allergy to the supplement, pregnant or breastfeeding women, or those not using effective contraception are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, the intervention could help people on incretin medications preserve lean muscle during weight loss, supporting better strength and metabolic health.

How similar studies have performed: High‑protein nutrition has been shown to help preserve lean mass during weight loss in other populations, but combining a diabetes-specific high‑protein formula with incretin-mimetic therapy has been relatively untested.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 Protality Base or Ensure Max Protein 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.

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Where this trial is running

Boston, Massachusetts

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

Study contacts

• Principal investigator: Osama Hamdy, MD, PhD — Joslin Diabetes Center
• Study coordinator: Jaime Jacob, BS

Conditions Type 2 Diabetes