Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: protein supplement.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Dietary supplement protein supplement
HP-DSF shakes provided by Abbott Nutrition
Primary outcome measures
- Change in lean muscle mass from baseline [Time frame: Endpoints will be analyzed at three months and six months.]
Eligibility criteria
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.
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Joslin Diabetes Center — Boston
Identifiers
NCT: NCT07271043 · STUDY00000322