Effects of Sitagliptin on Individuals with Genetic DPP4 Variants
Effects of Sitagliptin in Individuals With Genetically Decreased DPP4
This study is testing if the diabetes medication sitagliptin can help people with certain genetic variations that lower their DPP4 activity by looking at its effects on blood sugar and heart health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04323189 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial investigates the effects of sitagliptin, a DPP4 inhibitor, on individuals who have genetically decreased DPP4 activity. Participants will be randomly assigned to receive either sitagliptin or a placebo in a crossover design, with each intervention lasting seven days and separated by a four-week washout period. The study aims to measure changes in DPP4 activity, glucose levels after a mixed meal, and other cardiovascular parameters. It will include both cases with decreased DPP4 and matched controls, focusing on the potential benefits of sitagliptin in this specific genetic context.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with likely decreased DPP4 activity, as well as matched controls without this genetic variant.
Not a fit: Patients with significant medical conditions, recent hospitalizations, or those on certain diabetes medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into personalized treatment options for individuals with genetically decreased DPP4 activity, potentially improving outcomes in type 2 diabetes and heart failure.
How similar studies have performed: While the approach of targeting genetically defined populations is gaining traction, this specific investigation into DPP4 inhibition in individuals with genetic variants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jessica R Wilson, MD, MS — University of Pennsylvania
- Study coordinator: Jessica R Wilson, MD, MS
- Email: jessica.wilson3@uphs.upenn.edu
- Phone: (215) 898-3389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.