Effects of Sitagliptin in Individuals With Genetically Decreased DPP4

Description

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.

Conditions

Genetics Disease, Type2 Diabetes, Heart Failure

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Study Overview

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Study Details

Study overview

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.

Effects of Sitagliptin in Individuals With Genetically Decreased DPP4

Effects of Sitagliptin in Individuals With Genetically Decreased DPP4

Condition
Genetics Disease
Intervention / Treatment

-

Contacts and Locations

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Jessica R Wilson, MD, MS, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2024-12-31