Clinical Trial

The Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose in African Americans

Active, Not Recruiting Phase 4
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Summary
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2019-05-03; most recent amendment 2025-08-06.
Status change: Recruiting → Active, Not Recruiting 2023-08-10
Status change: Not Yet Recruiting → Recruiting 2020-02-18
Trial Details
NCT Number NCT03938389
Lead Sponsor Ohio State University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions PreDiabetes, Impaired Glucose Tolerance, Obesity, Blood Pressure
Enrollment 90 participants
Start Date 2020-02-25
Primary Completion 2024-02-08 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-08-11