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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07271043

Enrollment

Registered

2025-12-08

Start date

2026-01-01

Completion date

2026-12-01

Last updated

2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief 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.

Interventions

DIETARY_SUPPLEMENTprotein supplement

HP-DSF shakes provided by Abbott Nutrition

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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 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. \-

Design outcomes

Primary

Measure	Time frame
Change in lean muscle mass from baseline	Endpoints will be analyzed at three months and six months.

Countries

United States

Contacts

CONTACTMarwa Al-Badri, MD

marwa.albadri@joslin.harvard.edu6179758258

PRINCIPAL_INVESTIGATOROsama Hamdy, MD, PhD

Joslin Diabetes Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026