Phase 2
N=26
CD36 in Nutrient Delivery and Its Dysfunction
Insulin Resistance · Endothelial Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03012386 ↗Enrolled (actual)
26
Serious AEs
7.7%
Results posted
Nov 2022
Primary outcome: Primary: Change in Microvascular Blood Volume (MBV) During Insulin Infusion — 13.16; 11.3 ml/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sildenafil Citrate in G allele carrier (Drug); Sildenafil Citrate in non G allele carrier (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Microvascular Blood Volume (MBV) During Insulin Infusion |
13.16; 11.3 | — |
| PRIMARY Change in Microvascular Blood Volume (MBV) During Insulin Infusion After 4 Weeks of Sildenafil Treatment in Both Groups |
12.93; 8.4 | — |
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.
Eligibility Criteria
Inclusion criteria
- African American men and women.
- Age 18-50 years
- BMI 25-40 kg/m2
Exclusion criteria
- Diabetes type 1 or type 2, as defined by a FPG > 126 mg/dL a two-hour plasma glucose > 200 mg/dL, or the use of anti-diabetic medication
- Pulmonary hypertension
- Use of a PDE5 inhibitor for erectile dysfunction
- Pregnancy or breast-feeding. Women of child-bearing potential will be required to have undergone tubal ligation or to be using an oral contraceptive or barrier methods of birth control.
- Cardiovascular disease such as myocardial infarction, presence of angina pectoris, significant arrhythmia, congestive heart failure (left ventricular hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
- History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
- History or presence of immunological or hematological disorders
- Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
- Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
- History of alcohol or drug abuse
- Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study
- Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, unlikelihood of completing the study, and investigator discretion
Data sourced from ClinicalTrials.gov (NCT03012386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.