Heart Failure Clinical Trial
Official title:
Effects of Sitagliptin in Individuals With Genetically Decreased DPP4
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dipeptidyl peptidase 4 (DPP4) | DPP4 activity and antigen concentration | during study days 1 and 2 | |
Secondary | Glucose Area Under the Curve | Glucose will be measured before after the mixed meal during sitagliptin and placebo. Area under the curve will be calculated based on at least 10 time points after the meal. | Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2 | |
Secondary | Intact DPP4 substrates with cardiovascular properties (other than GLP-1) | Cardiovascular biomarkers include: CXCL12, substance P, neuropeptide Y, and brain natriuretic peptide. These are peptides that are also DPP4 substrates and are rapidly inactivated by this peptidase. | Before the meal (t=-15 or -1 min) on study days 1 and 2 | |
Secondary | Disposition index | Disposition index will be calculated from insulin sensitivity and insulin secretion. These variables will be computed using mathematical modeling of insulin and c-peptide. We will collect insulin and c-peptide at least 10 time points after the meal. | Calculated from samples collected before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2 | |
Secondary | Mean blood pressure | Measured via an automated blood pressure cuff approximately every 15 minutes | Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2 | |
Secondary | Glucagon-like peptide-1 (GLP-1) | This is released in response to a meal and rapidly degraded by DPP4. We will collect samples for at least six time points after the meal. | Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2 | |
Secondary | CD26 | CD26 is DPP4 on T cells and monocytes. | Before the meal or at baseline (t=-15 or -1 min) on study days 1 and 2 | |
Secondary | Surrogate markers of lipolysis | Triglycerides, free fatty acids; We will collect samples at least six time points after the meal. | Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2 | |
Secondary | Mean heart rate | Measured via an automated blood pressure cuff approximately every 15 minutes | Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|