Pharmacogenetics of Response to Sitagliptin (PRS) Study
This research study is looking at how different people respond to sitagliptin, a medication approved to treat diabetes. We are seeking healthy, non-diabetic volunteers from the Old Order Amish community in Lancaster, PA, aged 18 and older. The study aims to understand how sitagliptin affects early insulin release and glucose tolerance. You would participate in a 7-week study with two clinic visits, 4-6 weeks apart. During these visits, you'll have an oral glucose tolerance test (OGTT), where you drink a sugary liquid and have blood drawn to measure glucose and insulin levels. The study is currently unclear on its recruitment status.
- Study design
- This is an interventional study planning to enroll 400 participants. It is not specified if it's randomized or blinded.
- What's involved
- You would participate in a 7-week study with two clinic visits, 4-6 weeks apart. Each clinic visit will last about 5 hours and include an oral glucose tolerance test (OGTT) and other blood tests.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goals are measured at 6 weeks after starting sitagliptin, focusing on insulin secretion and glucose tolerance changes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pharmacogenetics of Response to Sitagliptin (PRS)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Amber L Beitelshees, PharmD, MPH · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore
- Simeon I Taylor, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Sitagliptin-induced enhancement of early insulin secretion6 weeks
This represents the incretinomimetic effect of sitagliptin, which contributes importantly to the mechanism whereby DPP4is decrease HbA1c in T2D patients. Because histograms for sitagliptin-induced increase in our index of early insulin secretion (T30:T60) demonstrated a skewed distribution, we will apply a logarithmic transformation of data which yields a normal distribution. Thus, the drug effect is defined as: log(T30:T60 ins)sita - log(T30:T60 ins)control.
- Sitagliptin-induced change in glucose tolerance6 weeks
Sitagliptin-induced change in glucose tolerance. This is a consequence of enhanced insulin secretion, which reflects most closely the desired effect of the drug to decrease plasma glucose and decrease HbA1c. Because histograms for sitagliptin-induced increase in our index of glucose tolerance (T30:T60) demonstrated a skewed distribution, we will apply a logarithmic transformation of data which yields a normal distribution. Thus, the drug effect is defined as: log(T30:T60 gluc)sita - log(T30:T60 gluc)control.