Status:
ACTIVE_NOT_RECRUITING
Effects of Sitagliptin in Individuals With Genetically Decreased DPP4
Lead Sponsor:
University of Pennsylvania
Conditions:
Genetics Disease
Type2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This is a pilot clinical trial to test the hypothesis that during sitagliptin (DPP4 inhibitor), individuals heterozygous for DPP4 loss of function variants will have a reduction in DPP4 activity and a...
Detailed Description
Participants of this pilot clinical trial will be randomized in a blinded 2:2 crossover manner to receive placebo and sitagliptin 100 mg/d (DPP4 inhibitor), in random order. Subjects will receive each...
Eligibility Criteria
Inclusion
- Participant of the Penn Medicine Biobank who is willing to be recontacted to participate in future research.
- Cases are defined as adults 18-70 years with likely decreased DPP4.
- Controls are defined as adults who are matched to cases by: age, gender, race, BMI, hypertension status, diabetes status, renal function, and medication use that may affect outcomes of interest.
Exclusion
- The study will exclude volunteers with any significant medical conditions that may interfere with study participation, data interpretation, or pose safety risk(s) to the subject.
- Recent hospitalization or acute illness such as infection within the past two weeks
- Pregnancy
- Use of insulin
- Use of a GLP-1 agonist or DPP4 inhibitor medication
- Use of oral diabetes agents other than metformin unless matched with controls
- Type 1 diabetes
- Chronic steroid use or use within the last 30 days
- Significant liver disease including liver enzymes \>3 x upper limit of normal range
- Renal dysfunction defined as eGFR\< 50mL/min/1.73m2
- Significant cardiac disease such as heart transplantation
- Significant gastrointestinal conditions that may interfere with drug absorption or GLP-1 release including bariatric surgery
- Significant hematologic disease such as hematocrit \<35%
- Use of chronic anticoagulation
- Severe pulmonary disease
- Severe neurologic or psychiatric disease
- Inability to comprehend study procedures
Key Trial Info
Start Date :
August 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04323189
Start Date
August 26 2020
End Date
February 28 2026
Last Update
November 24 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104