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

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study completion date: Jun 2025 to Jun 2026v9
  2. Minor Primary completion date changed from estimate of Jan 2024 to Feb 8, 2024
    • Study completion date: Jun 2024 to Jun 2025
    v8
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Aug 2023 to Jan 2024
    • Study completion date: Aug 2023 to Jun 2024
    • Site details revised
    v7
  4. Notable Primary completion date: Aug 2022 to Aug 2023
    • Study completion date: Dec 2022 to Aug 2023
    v6
  5. Notable Primary completion date: Aug 2021 to Aug 2022
    • Study completion date: Dec 2021 to Dec 2022
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2020 to Feb 25, 2020
    • Site details revised
    v4
  2. Notable Start date: Dec 2019 to Mar 2020v3
  3. Notable Start date: Jul 2019 to Dec 2019v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT03938389
Lead Sponsor Ohio State University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)
PreDiabetes, Impaired Glucose Tolerance, Obesity, Blood Pressure
Related terms Glucose Intolerance, Obesity, Prediabetic State
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov