Viewing Study NCT03012386



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Last Modification Date: 2024-10-26 @ 12:16 PM
Study NCT ID: NCT03012386
Status: COMPLETED
Last Update Posted: 2022-11-30
First Post: 2017-01-03

Brief Title: CD36 in Nutrient Delivery and Its Dysfunction
Sponsor: Vanderbilt University Medical Center
Organization: Vanderbilt University Medical Center

Study Overview

Official Title: Role of CD36 in Nutrient Delivery and Its Dysfunction in African Americans
Status: COMPLETED
Status Verified Date: 2022-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: Subjects carrying the G-allele of CD36 coding SNP rs3211938 that results in 50 reduction of CD36 levels in 25 of African Americans have endothelial dysfunction Endothelial dysfunction results in impairment of insulins vascular actions and eventually reduced insulin sensitivity Insulin induces microvascular recruitment via stimulation of nitric oxideNO-cGMP pathway which facilitates nutrient flux eg glucose to skeletal muscle Elevated fatty acids impair insulin-stimulated microvascular recruitment and reduce insulin sensitivity Chronic treatment with sildenafil increases vascularity and muscle glucose uptake in high fat fed mice In humans Drs Shibao PI recently reported that a 3-month treatment with sildenafil improves insulin sensitivity in patients with impaired glucose tolerance More relevant to this project endothelial dysfunction improved after 4-week treatment with sildenafil in G-allele carriers This proposal will test the hypothesis that chronic treatment with sildenafil with and without the use of NO substrate L-arginine protects against fatty acids induced impairment of endothelial function improves insulin-stimulated microvascular

The protocol design was changed to single arm design

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None