NCT03938389

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

The Role of the Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose Metabolism Among African Americans: Pilot Study

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PreDiabetes
• Impaired Glucose Tolerance
• Obesity
• Blood Pressure

Interventions

Type	Name	Description
DRUG	Sacubitril-Valsartan Tab 97-103 MG	Participants will take Sacubitril-Valsartan for 26 weeks
DRUG	Valsartan 160mg	Participant will take Valsartan for 26 weeks
DRUG	Placebo Oral Tablet	Participant with take placebo for 26 weeks or if blood pressure elevated will receive standard of care blood pressure medication, amlodipine.

Timeline

• Start date: 2020-02-25
• Primary completion: 2024-02-08
• Completion: 2026-06-01
• First posted: 2019-05-06
• Last updated: 2025-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study