Obesity Clinical Trial
— PORTOfficial title:
Pharmacogenetics of Response to GLP1R Agonists
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 31, 2027 |
Est. primary completion date | November 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria: - BMI greater than or equal to 27 kg/m2 - Of Amish Descent Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Amish Research Clinic | Lancaster | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Insulin sensitivity (Si) | Estimated using Bergman's minimal model | Measured both at baseline and after completing 6 weeks of semaglutide therapy | |
Other | Glucose effectiveness (Sg) | Estimated using Bergman's minimal model | Measured both at baseline and after completing 6 weeks of semaglutide therapy | |
Primary | First phase insulin secretion | Area under the curve for plasma insulin levels measured at times between 0-10 min after administration of intravenous glucose (0.3 g/kg) | Measured both at baseline and after completing 6 weeks of semaglutide therapy | |
Primary | Second phase insulin secretion | Area under the curve for plasma insulin levels measured at times between 10-50 min after administration of intravenous glucose (0.3 g/kg) | Measured both at baseline and after completing 6 weeks of semaglutide therapy | |
Primary | Rate of glucose disappearance | Slope of the plot of log(glucose concentration) as a function of time. This will be calculated based on a linear regression using data points between 25-50 minutes after administration of intravenous glucose (0.3 g/kg) | Measured both at baseline and after completing 6 weeks of semaglutide therapy | |
Secondary | Weight loss | This will be measured as the baseline weight in kg minus the weight after completing 6 weeks of semaglutide therapy. | Assessed after completing 6 weeks of semaglutide therapy |
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