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Not yet recruiting NCT06813014

Pharmacogenetics of Response to Sitagliptin (PRS)

Phase IV Interventional Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral Glucose Tolerance Test.
Who it may be relevant to
Registry conditions: Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Oral Glucose Tolerance Test
    Three hour glucose tolerance test

Primary outcome measures

  • Sitagliptin-induced enhancement of early insulin secretion [Time frame: 6 weeks]
  • Sitagliptin-induced change in glucose tolerance [Time frame: 6 weeks]
Secondary outcome measures (5)
  • Area under the curve for insulin concentration [Time frame: 6 weeks]
  • Area under the curve for glucose concentration [Time frame: 6 weeks]
  • Area under the curve for intact GIP [Time frame: 6 weeks]
  • Area under the curve for intact GLP1 [Time frame: 6 weeks]
  • Area under the curve for C-peptide levels [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Maryland Amish Research Clinic — Lancaster

Identifiers

NCT: NCT06813014 · HP-00111892

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗