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NCT Number: NCT07271043

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Adham Mottalib, MD

SUB_INVESTIGATOR

Marwa Al-Badri, MD

CONTACT

[email protected]

6179758258

Osama Hamdy, MD., PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Protein Supplement

Dietary Supplement

HP-DSF shakes provided by Abbott Nutrition

Primary outcomes

  1. Change in lean muscle mass from baseline

    Time frame: Endpoints will be analyzed at three months and six months.

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa Al-Badri, MD

CONTACT

[email protected]

6179758258

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • Abbott

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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