Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Genetics Disease
  • Heart Failure
  • Type2 Diabetes
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: blinded 2:2 crossover, placebo-controlledMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Neither subjects, nor the investigator or key study personnel will know drug randomization until after data analyses are completed.Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

Participants of this pilot clinical trial will be randomized in a blinded 2:2 crossover manner to receive placebo and sitagliptin 100 mg/d (DPP4 inhibitor), in random order. Subjects will receive each intervention for seven days, with a study day on day 7. Each intervention will be separated by a 4-...

Participants of this pilot clinical trial will be randomized in a blinded 2:2 crossover manner to receive placebo and sitagliptin 100 mg/d (DPP4 inhibitor), in random order. Subjects will receive each intervention for seven days, with a study day on day 7. Each intervention will be separated by a 4-week washout period. Each subject will have up to four separate visits: 1) DXA, echocardiogram, 2) cardiac MRI, 3) mixed meal during placebo, 4) mixed meal during sitagliptin. The study will include 10 cases and 10 controls. Among these, there will be five heterozygous cases and five matched controls with elevated blood pressure (history of blood pressure 130/80 on more than one occasion or prior diagnosis of hypertension by a medical provider) and five cases and five controls without hypertension.

Tracking Information

NCT #
NCT04323189
Collaborators
Not Provided
Investigators
Principal Investigator: Jessica R Wilson, MD, MS University of Pennsylvania
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