RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-12
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06003153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males or non-pregnant females
  2. 2. Ages 18-50 (inclusive)
  3. 3. Able/willing to give consent
  4. 4. Span the metabolic range between normal glycemia and pre-diabetes (fasting glucose of 100-125 mg/dL based on chart review of existing laboratory data)
  1. 1. Currently taking medications or intending to take medications for diabetes
  2. 2. Currently taking medications or intending to take medications that affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
  3. 3. Personal history of intestinal malabsorption, bariatric surgery, celiac disease, gallbladder disease, or pancreatitis
  4. 4. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
  5. 5. Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2 per the Modification of Diet in Renal Disease equation
  6. 6. History of cirrhosis and/or aspartate aminotransferase or alanine aminotransferase more than 3x upper limit of normal
  7. 7. Dietary restrictions preventing consumption of a MMTT
  8. 8. Women who are pregnant, nursing, or at risk of becoming pregnant
  9. 9. Participation in other interventional studies during the current study

Contacts and Locations

Study Contact

Varinderpal Kaur
CONTACT
6176435419
vkaur@mgh.harvard.edu
Josephine Li
CONTACT
617-643-4987
jli71@mgh.harvard.edu

Principal Investigator

Josephine Li, MD
PRINCIPAL_INVESTIGATOR
MGH

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Josephine Li, MD, PRINCIPAL_INVESTIGATOR, MGH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-12
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2024-03-12
Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Genetic Predisposition
  • Metabolic Diseases
  • Type 2 Diabetes