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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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.

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Where it's running

• Joslin Diabetes Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Osama Hamdy, MD, PhD — Joslin Diabetes Center
• Study coordinator: Marwa Al-Badri, MD
• Email: marwa.albadri@joslin.harvard.edu
• Phone: 6179758258

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.