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

Joslin Diabetes Center

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: protein supplement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07271043

STUDY00000322

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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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Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Participants will be instructed to drink two HP-DSF shakes (Protality Base or Ensure Max Protein by

Experimental group

Treatment:

Dietary Supplement: protein supplement

Participants in this control group will follow the regular standard of diabetes care

No Intervention group