Pharmacogenetics of Response to GLP1R Agonists

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.

Conditions

Obesity, Diabetes Type 2

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Study Overview

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Study Details

Study overview

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.

Pharmacogenetics of Response to GLP1R Agonists

Pharmacogenetics of Response to GLP1R Agonists

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Lancaster

Amish Research Clinic, Lancaster, Pennsylvania, United States, 17602

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * BMI greater than or equal to 27 kg/m2
  • * Of Amish Descent
  • * Woman of childbearing age who is sexually active
  • * History of diabetes (HbA1c \> 6.5% or random glucose \>200 mg/dL)
  • * Known allergy to semaglutide
  • * Medical issues, which in the judgment of the research physician or PIs might increase the risk associated with participation in the study
  • * eGFR \< 60 mL/min/1.73 sq. m.
  • * Hematocrit \< 35%
  • * TSH \< 0.4 o4 \> 5.5
  • * AST or ALT in excess of 2X the upper limit of normal
  • * 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
  • * Personal or family history of medullary carcinoma of the thyroid or multiple endocrine neoplasia, type 2

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Maryland, Baltimore,

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

Study Record Dates

2027-12-31