Clinical trial
Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics
Recruiting now · Not applicable · 1 countries · Registry ID NCT07271043
Recruiting nowNot applicableInterventional
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes
Full registry 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. \-
Treatments and study arms
protein supplement
Dietary Supplement
HP-DSF shakes provided by Abbott Nutrition
Primary outcomes
Change in lean muscle mass from baselineEndpoints will be analyzed at three months and six months.
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Joslin Diabetes Center🇺🇸 Boston, Massachusetts, United States
Marwa Al-Badri, MDContact
Osama Hamdy, MD., PhDPrincipal Investigator
Adham Mottalib, MDSub Investigator