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

NCT07271043 | Recruiting

• 1 other identifier: STUDY00000322
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in lean muscle mass from baseline

  Endpoints will be analyzed at three months and six months.

Study Arms (2)

Participants will be instructed to drink two HP-DSF shakes

EXPERIMENTAL

Dietary Supplement: protein supplement

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

NO INTERVENTION

Interventions

protein supplement DIETARY_SUPPLEMENT

HP-DSF shakes provided by Abbott Nutrition

Participants will be instructed to drink two HP-DSF shakes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• Abbott: collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Osama Hamdy, MD, PhD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa Al-Badri, MD

CONTACT

6179758258; marwa.albadri@joslin.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

US (1)