Recruiting

HPDSF with Incretin-mimetic

Sponsor:

Joslin Diabetes Center

Code:

NCT07271043

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

protein supplement

Study Details

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

Study ID

NCT07271043

Start date

Jan 1, 2026

Status verified date

May, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

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Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Participants will be instructed to drink two HP-DSF shakes

no intervention: Participants in this control group will follow the regular standard of diabetes care

Interventions

protein supplement

HP-DSF shakes provided by Abbott Nutrition

Primary outcome measure

  • Change in lean muscle mass from baseline [ Time Frame: Endpoints will be analyzed at three months and six months. ]

Central Contacts and Locations

Central contacts

Locations

Joslin Diabetes Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Osama Hamdy, MD., PhD

More Information

Sponsor

Joslin Diabetes Center

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Joslin Diabetes Center on 2026-05-29.