ACTIVE_NOT_RECRUITING

Effects of Sitagliptin in Individuals With Genetically Decreased DPP4

Conditions

Genetics Disease Type2 Diabetes Heart Failure genetics sitagliptin DPP4 inhibition type 2 diabetes

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Effects of Sitagliptin in Individuals With Genetically Decreased DPP4

Quick Facts

Study Start:2020-08-26

Study Completion:2026-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04323189

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Jessica R Wilson, MD, MS

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-26

Study Completion Date2026-02-28

Study Record Updates

Study Start Date2020-08-26

Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

genetics
sitagliptin
DPP4 inhibition
heart failure
type 2 diabetes

Additional Relevant MeSH Terms

Genetics Disease
Type2 Diabetes
Heart Failure