Actively Recruiting
Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics
Led by Joslin Diabetes Center · Updated on 2026-01-30
60
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
J
Joslin Diabetes Center
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with type 2 diabetes at least 3 months before screening
- About to start treatment with an incretin mimetic drug, including semaglutide, tirzepatide, or dulaglutide
- Body mass index (BMI) of 25 kg/m2 or higher
You will not qualify if you...
- Diagnosis of type 1 diabetes mellitus
- Estimated glomerular filtration rate (eGFR) below 60 milliliters/minute/1.73 m2
- Urine albumin-to-creatinine ratio (UACR) of 300 mg/g or higher
- History of acute kidney injury within 6 months before screening
- Allergy or intolerance to Protality Base, Ensure Max Protein, or their ingredients
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Women of childbearing potential not using highly effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
J
Jaime Jacob, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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