CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Sildenafil Citrate in G allele carrier +1 moredrug
Likely dose
Sildenafil citrate (chronic use as a PDE5 inhibitor; specific dose not stated)AI-extracted
Key inclusion· 3
  • African American men and women
  • Age 18-50 years
  • BMI 25-40 kg/m²
Key exclusion· 8
  • Diabetes type 1 or type 2 (FPG >126 mg/dL, 2-hour glucose >200 mg/dL, or on anti-diabetic medication)
  • Pulmonary hypertension
  • Prior use of PDE5 inhibitor for erectile dysfunction
  • Cardiovascular disease (MI, angina, significant arrhythmia, CHF, DVT, PE, heart block, valve disease, hypertrophic cardiomyopathy)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03012386
NCT03012386Phase 2Completed

Role of CD36 in Nutrient Delivery and Its Dysfunction in African Americans

Vanderbilt University Medical Center·interventional·Posted Jan 6, 2017·Updated Nov 30, 2022

In Brief

A Phase 2 clinical trial evaluating Sildenafil Citrate in G allele carrier and Sildenafil Citrate in non G allele carrier for Insulin Resistance and Endothelial Dysfunction. Completed, enrolled 26 participants across 1 site.

Detailed Summary

This proposal will test the hypothesis that chronic treatment with sildenafil with and without the use of nitric oxide substrate, L-arginine, protects against fatty acid induced impairment of endothelial function, improves insulin-stimulated microvascular recruitment, insulin sensitivity and glucose uptake in CD36 rs3211938 G-allele carriers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 6, 2017
Enrollment StartJan 1, 2017
Primary CompletionJul 1, 2021
Study CompletionJul 31, 2021
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.5 years ago

Interventions

Sildenafil Citrate in G allele carrierdrug

chronic use of phosphodiesterase 5 inhibitor in G allele carrier

Sildenafil Citrate in non G allele carrierdrug

chronic use of phosphodiesterase 5 inhibitor in Non G allele carrier