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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Participants will be instructed to drink two HP-DSF shakes
  • Dietary Supplement: protein supplement
    HP-DSF shakes provided by Abbott Nutrition
No Intervention
Participants in this control group will follow the regular standard of diabetes care

Recruiting Locations

Joslin Diabetes Center
Boston, Massachusetts 02215
Contact:
Marwa Al-Badri, MD
6179758258
marwa.albadri@joslin.harvard.edu

More Details

Status
Recruiting
Sponsor
Joslin Diabetes Center

Study Contact

Marwa Al-Badri, MD
6179758258
marwa.albadri@joslin.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.