NCT07271043Recruiting
Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics
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
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 Nov 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Joslin Diabetes Center
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07271043
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Jan 2026 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of acute kidney injury (AKI) during the 6 months prior to screening g.
Other illness
- Subject has type 1 diabetes mellitus
- Intolerance or allergy to HP-DSF shake or to any of its ingredients
Lab values
- Urine albumin-to-creatinine ratio (UACR) of 300 mg/g or higher
Other
- Subject with estimated glomerular filtration rate \<60 milliliters/minute/1.73 m²,
- 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.
- \-
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Joslin Diabetes Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.