Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics
NCT ID: NCT07271043
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2026-01-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Participants will be instructed to drink two HP-DSF shakes (Protality Base or Ensure Max Protein by
protein supplement
HP-DSF shakes (Protality Base or Ensure Max Protein by Abbott Nutrition)
Participants in this control group will follow the regular standard of diabetes care
No interventions assigned to this group
Interventions
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protein supplement
HP-DSF shakes (Protality Base or Ensure Max Protein by Abbott Nutrition)
Eligibility Criteria
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Inclusion Criteria
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
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 Protality Base or Ensure Max Protein 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.
\-
18 Years
75 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Joslin Diabetes Center
OTHER
Responsible Party
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Principal Investigators
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Osama Hamdy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Joslin Diabetes Center
Locations
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Joslin Diabetes Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00000322
Identifier Type: -
Identifier Source: org_study_id
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