Sitagliptin's Effects on Glucose-stimulated Insulin Secretion and Oral Glucose

Official Summary

This is a research study to find out how different people respond to a medication called sitagliptin. Sitagliptin is an FDA approved medication that is used to treat diabetes. We are asking for healthy, non-diabetic volunteers to participate in this 7-week study. If you agree to participate, you will take part in 2 clinic visits that are 4-6 weeks apart. At the clinic visits you will have an oral glucose tolerance test (OGTT) and other blood tests to see how your body processes glucose (sugar). An OGTT is a test in which your drink glucose and then blood samples are taken afterward at specific time points to measure glucose and insulin in your blood. Each clinic visit will last about 5 hours.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: CROSSOVER
• Masking: SINGLE
• Enrollment: 400 participants

Interventions

• PROCEDURE: Oral Glucose Tolerance Test — Three hour glucose tolerance test

Primary Outcomes

• Sitagliptin-induced enhancement of early insulin secretion (6 weeks)
• Sitagliptin-induced change in glucose tolerance (6 weeks)

Secondary Outcomes

• Area under the curve for insulin concentration (6 weeks)
• Area under the curve for glucose concentration (6 weeks)
• Area under the curve for intact GIP (6 weeks)
• Area under the curve for intact GLP1 (6 weeks)
• Area under the curve for C-peptide levels (6 weeks)

Trial Locations

• University of Maryland Amish Research Clinic, Lancaster, Pennsylvania, United States

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