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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how a high-protein nutrition shake made for people with diabetes affects muscle mass. It is for adults with type 2 diabetes who are overweight or obese and are about to start certain diabetes medicines.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 75 years old.
  • You were diagnosed with type 2 diabetes at least 3 months before screening.
  • You are about to start semaglutide (Ozempic or Wegovy), tirzepatide (Mounjaro or Zepbound), or dulaglutide (Trulicity). These medicines act like hormones that help control blood sugar.
  • Your body mass index (BMI), a measure of weight compared with height, is 25 or higher.

Who can't join

  • You have type 1 diabetes.
  • Your estimated kidney filtering rate (eGFR) is below 60 mL/min/1.73 m².
  • Your urine albumin-to-creatinine ratio (UACR), a measure of protein in urine, is 300 mg/g or higher.
  • You had a sudden kidney injury in the 6 months before screening.
  • You are allergic to the study shake or any of its ingredients, or cannot tolerate it.
  • You are pregnant or breastfeeding, or expect to be during the study.
  • You are a woman who could become pregnant and are not using highly effective birth control.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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. \-

Study sites (1)

MA