Effects of Sitagliptin in Individuals With Genetically Decreased DPP4

Launched by UNIVERSITY OF PENNSYLVANIA · Mar 25, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called sitagliptin affects people with a specific genetic condition that reduces the activity of an enzyme called DPP4. Researchers want to see if taking sitagliptin can lower blood sugar levels after eating and improve other health markers compared to a placebo (a non-active treatment). The trial is looking for participants aged 18 to 70 who have this genetic variation and are part of the Penn Medicine Biobank. They will compare these individuals to others who are similar in age, gender, and health conditions but do not have the genetic issue.

Participants in the trial can expect to either receive sitagliptin or a placebo for a period of time, and their health will be monitored throughout the study. To join, individuals should not have serious health issues that could interfere with the study or pose risks, such as recent hospitalizations, pregnancy, or certain other medical conditions. This is an important step in understanding how genetics can influence diabetes treatment and could lead to better care for people with similar issues in the future.

Gender

ALL

Eligibility 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