Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics
Recruiting · NCT07271043 · Interventional (participants receive a specific treatment) · Lead sponsor: Joslin Diabetes Center
View the official record on ClinicalTrials.gov →Interventions studied
protein supplement
What this trial is about
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 take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 HP-DSF shake 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.
Where it is running
1 location listed across 1 US state.
- Joslin Diabetes Center - Boston, Massachusetts, United States