The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
NCT Number: NCT03938389
The primary objective is to examine the impact of the Renin-Angiotensin-Aldosterone System (RAAS) blockade with medications (valsartan) or RAAS and neprilysin inhibition (valsartan/sacubitril) vs. placebo on changes in blood sugar and insulin secretion from the pancreas over 26 weeks assessed with glucose clamp studies among African Americans (AAs) with impaired glucose tolerance.
The investigators hypothesize that combined RAAS/neprilysin inhibition will lead to greater improvement in insulin release from the pancreas and improved blood sugar compared to RAAS inhibition alone among AAs with impaired glucose tolerance.
This study is active but is not currently recruiting participants.
18 year–65 year
All sexes
Interventional
Phase 4
Columbus, Ohio, 43210, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Severe Psychiatric Disorders:
Participants will take Sacubitril-Valsartan for 26 weeks
Other names: Entresto
Participant will take Valsartan for 26 weeks
Other names: Diovan
Participant with take placebo for 26 weeks or if blood pressure elevated will receive standard of care blood pressure medication, amlodipine.
Time frame: 26 weeks
β-cell function will be assessed by first-phase insulin secretion, calculated as the mean insulin concentration (uIU/mL) over 10 minutes during the hyperglycemic clamp.
Time frame: 26 weeks
Central Aortic Pressure, measured via a non-invasive method using the SphygmoCor XCEL device, in mmHg.
Ohio State University
Other
The Role of the Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose Metabolism Among African Americans: Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05056376
Behavior, Body Weight
Baltimore, Maryland, United States
View Trial DetailsNCT04743856
Behavior, Blood Pressure
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT05387551
Body Weight, Diabetes Mellitus
Jacksonville, Florida, United States
View Trial DetailsNCT06055036
Behavior, Blood Pressure
Columbus, Ohio, United States
View Trial Details