NCT07271043 Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics
| NCT ID | NCT07271043 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Joslin Diabetes Center |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-01-01 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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. \-
Contact & Investigator
Osama Hamdy, MD, PhD
PRINCIPAL INVESTIGATOR
Joslin Diabetes Center
Frequently Asked Questions
Who can join the NCT07271043 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07271043 currently recruiting?
Yes, NCT07271043 is actively recruiting participants. Contact the research team at marwa.albadri@joslin.harvard.edu for enrollment information.
Where is the NCT07271043 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07271043 clinical trial?
NCT07271043 is sponsored by Joslin Diabetes Center. The principal investigator is Osama Hamdy, MD, PhD at Joslin Diabetes Center. The trial plans to enroll 60 participants.
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