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.

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NCT06813014

Pharmacogenetics of Response to Sitagliptin (PRS)

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Maryland, Baltimore
~400 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:Oral Glucose Tolerance Test

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sitagliptin-induced enhancement of early insulin secretion
Measured over 6 weeks
+1 more outcome measured
Diabetes
1 sites across 1 states
Pennsylvania1
  • Amber L Beitelshees, PharmD, MPH · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore
  • Simeon I Taylor, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore

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Eligibility criteria

Inclusion

• Age: \>18 years old
Members of Old Order Amish community in Lancaster, PA

Exclusion

• Pregnancy (reproductive age women will undergo pregnancy tests immediately before receiving the drug)
Diabetes: HbA1c \> 6.5% or fasting plasma glucose \>126 mg/dL
Estimated glomerular filtration rates (eGFR) \<60 mL/min/1.73 m2
Anemia: hematocrit \< 35%
Thyroid status: TSH\<0.4 or TSH\>5.5
ALT or AST in excess of 2X upper limit of normal
Drugs that in the physician's judgment would alter response to sitagliptin
Significant health issues that in the physician's judgment could increase the risk for participants.
  • 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.