Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics

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

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 Protality Base or Ensure Max Protein 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.

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Conditions2

Locations1 site

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