Pharmacogenetics of Response to Sitagliptin (PRS)

NCT ID: NCT06813014

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2032-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sitagliptin

Sitagliptin 100 mg given 2 hours prior to the oral glucose tolerance test

Group Type EXPERIMENTAL

Oral Glucose Tolerance Test

Intervention Type PROCEDURE

Three hour glucose tolerance test

Placebo

Placebo given 2 hours prior to the oral glucose tolerance test

Group Type PLACEBO_COMPARATOR

Oral Glucose Tolerance Test

Intervention Type PROCEDURE

Three hour glucose tolerance test

Interventions

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Oral Glucose Tolerance Test

Three hour glucose tolerance test

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Amber Beitelshees

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amber L Beitelshees, PharmD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Simeon I Taylor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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University of Maryland Amish Research Clinic

Lancaster, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Amber L Beitelshees

Role: CONTACT

Phone: 14107060118

Email: [email protected]

Kamah Woelfel

Role: CONTACT

Email: [email protected]

Other Identifiers

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HP-00111892

Identifier Type: -

Identifier Source: org_study_id