Effects of Sitagliptin in Individuals With Genetically Decreased DPP4

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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 antigen, lower glucose after a mixed meal, and higher levels of intact DPP4 substrates compared to during placebo and compared to matched controls.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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