What this study is
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.
What's being tested
- Semaglutide Pen Injector [Ozempic]
Intervention · DRUG
Participants will receive subcutaneously injected semaglutide (0.25 mg/wk) for 4 weeks followed by semaglutide (0.5 mg/wk) for an additional two weeks.
Study details
- Sponsor
- University of Maryland, Baltimore
- Conditions
- Obesity · Diabetes Type 2
- Enrolling
- 600 people
- Starts
- 2022-04-11
- Est. completion
- 2028-04
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 89 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- BMI greater than or equal to 27 kg/m2
- Of Amish Descent
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openAmish Research Clinic
Lancaster, Pennsylvania, United States
- Susan Shaub, RN · Contact(717)392-4948sshaub@som.umaryland.edu
Recruiting
Study team
Sponsor
University of Maryland, Baltimore
Study ID HP00097563
Principal investigator
Amber L Beitelshees, PharmD
University of Maryland, Baltimore
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.