RECRUITING

Pharmacogenetics of Response to GLP1R Agonists

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

Overweight/obese otherwise healthy volunteers will be recruited from the Old Order Amish population in Lancaster County, PA. Lancaster County, PA. Pharmacodynamic responses to GLP1R agonist will be assessed by conducting frequently sampled intravenous glucose tolerance tests (FSIGT) both before and after semaglutide for six weeks. The proposal proposes two specific aims: 1. Specific Aim #1. To identify genetic variants associated with effects of a GLP1R agonist to enhance glucose-stimulated first phase insulin secretion in the two FSIGTs (before and after administration of drug). 2. Specific Aim #2. To identify genetic variants associated with the effect of a GLP1R agonist to accelerate the rate of glucose disappearance as assessed in the two FSIGTs (before and after administration of drug). Genotyping will be conducted using a high-density array with comprehensive coverage of DNA sequence variants. In addition, the analysis will leverage a global imputation panel generated from 1,025 Amish individuals.

Official Title

Pharmacogenetics of Response to GLP1R Agonists

Quick Facts

Study Start:2022-04-11
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05071898

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 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * BMI greater than or equal to 27 kg/m2
  2. * Of Amish Descent
  1. * Woman of childbearing age who is sexually active
  2. * History of diabetes (HbA1c \> 6.5% or random glucose \>200 mg/dL)
  3. * Known allergy to semaglutide
  4. * Medical issues, which in the judgment of the research physician or PIs might increase the risk associated with participation in the study
  5. * eGFR \< 60 mL/min/1.73 sq. m.
  6. * Hematocrit \< 35%
  7. * TSH \< 0.4 o4 \> 5.5
  8. * AST or ALT in excess of 2X the upper limit of normal
  9. * Unable to discontinue a drug, vitamin, or nutritional supplement, which in the judgment of the research physician or PIs might alter the response to semaglutide
  10. * Personal or family history of medullary carcinoma of the thyroid or multiple endocrine neoplasia, type 2

Contacts and Locations

Study Contact

Amber L Beitelshees, PharmD
CONTACT
(410)706-0118
abeitels@som.umaryland.edu
Simeon I Taylor, MD, PhD
CONTACT
(410)706-6439
staylor2@som.umaryland.edu

Principal Investigator

Amber L Beitelshees, PharmD
PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore

Study Locations (Sites)

Amish Research Clinic
Lancaster, Pennsylvania, 17602
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

  • Amber L Beitelshees, PharmD, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

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 Date2022-04-11
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2022-04-11
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • GLP-1 receptor agonist
  • Insulin secretion
  • Insulin sensitivity
  • Pharmacogenomics
  • Semaglutide

Additional Relevant MeSH Terms

  • Obesity
  • Diabetes Type 2