Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06003153 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH

Study acronym: GLUCOSE-MGH
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv8
  2. Eligibility criteria revised Site contact updatedv7 Show 1 more changeShow less
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv6
  4. Interventions: Mixed Meal Tolerance Test (MMTT) (Other), Rybelsus (Drug) to Mixed Meal Tolerance Test (MMTT) (Other), oral semaglutide (Drug) Study description expanded, about 146 wordsv5 Show 1 more changeShow less
    • Study description expanded, about 146 words

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary and study completion dates: Dec 30, 2027 to May 31, 2027v3
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 1, 2023 to Mar 12, 2024 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date changed from estimate of Oct 1, 2023 to Mar 12, 2024
    • Study sites: 0 to 1
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this research study is to evaluate the pathophysiologic mechanisms by which genetic variation impacts response to an FDA-approved medication commonly used to treat type 2 diabetes called oral semaglutide (Rybelsus) and to characterize the physiological response to a mixed meal tolerance test (MMTT) before and after a 14-day treatment with oral semaglutide. The investigators will do this by measuring factors in the blood, such as sugars, fats, metabolites, and proteins, after eating a standardized breakfast meal at the first visit and after taking 14 doses of oral semaglutide over two weeks before the second study visit. The food (mixed meal breakfast) we will be studying is specially prepared to contain a set amount of protein, carbohydrates, and fat. The investigators hypothesize that understanding how the acute biochemical response to oral semaglutide differs by genetic variation will generate insight into drug mechanisms and type 2 diabetes pathophysiology.
Trial Details
NCT Number NCT06003153
Lead Sponsor Massachusetts General Hospital
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Genetic Predisposition, Metabolic Diseases, Type 2 Diabetes
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov