CD36 in Nutrient Delivery and Its Dysfunction
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|ClinicalTrials.gov Identifier: NCT03012386|
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : January 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance Endothelial Dysfunction||Drug: Sildenafil Citrate||Phase 1 Phase 2|
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 insulin's vascular actions and eventually reduced insulin sensitivity. Insulin induces microvascular recruitment via stimulation of nitric oxide(NO)-cGMP pathway, which facilitates nutrient flux, e.g., 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Role of CD36 in Nutrient Delivery and Its Dysfunction in African Americans|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||October 2021|
Experimental: Sildenafil citrate
Sildenafil citrate 20 mg three times a day
Drug: Sildenafil Citrate
phosphodiesterase 5 inhibitor
Other Name: viagra, revatio,
- insulin-stimulated microvascular recruitment. [ Time Frame: 4 weeks ]The primary endpoint is the change in microvascular blood volume (ΔMBV) during insulin infusion from baseline, an index of insulin-stimulated microvascular recruitment.
- Insulin sensitivity [ Time Frame: 4 weeks ]Glucose infusion rate during hyperinsulinemic euglycemic clamp
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012386
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Cyndya Shibao, MD||Vanderbilt University Medical Center|