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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

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

Clinicaltrials.gov identifier NCT03938389

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted February 20, 2020

Study Description

Brief 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.

  • Condition or Disease:PreDiabetes
    Impaired Glucose Tolerance
    Obesity
    Blood Pressure
  • Intervention/Treatment: Drug: Sacubitril-Valsartan Tab 97-103 MG
    Drug: Valsartan 160mg
    Drug: Placebo Oral Tablet
  • Phase: Phase 4
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 90 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Randomized prospective controlled clinical trial with three parallel arms, no crossover.
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: The Role of the Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose Metabolism Among African Americans: Pilot Study
  • Estimated Study Start Date: February 2020
  • Estimated Primary Completion Date: August 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Sacubitril/Valsartan
Sacubitril/Valsartan (97/103 mg) twice daily for 26 weeks
Drug: Sacubitril-Valsartan Tab 97-103 MG
Participants will take Sacubitril-Valsartan for 26 weeks
Active Comparator: Valsartan
Valsartan 160 mg twice daily for 26 weeks
Drug: Valsartan 160mg
Participant will take Valsartan for 26 weeks
Placebo Comparator: Placebo
placebo (+/- amlodipine 2.5-5 mg twice daily if high blood pressure)
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.
Outcome Measures
  • Primary Outcome Measures: 1. Change from Baseline to 26 weeks in β-cell function (first-phase insulin secretion) [ 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.
  • Secondary Outcome Measures: 1. Change in Central Aortic Pressure (mmHg) from Baseline to 26 weeks [ Time Frame: 26 weeks ]
    Central Aortic Pressure, measured via a non-invasive method using the SphygmoCor XCEL device, in mmHg.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- African Americans aged 18-65 years old with a history of impaired fasting glucose,
impaired glucose tolerance, hemoglobin A1c 5.7-6.4% or other risk factors for diabetes
including metabolic syndrome, family history of type 2 diabetes in the parents or
siblings or history of gestational diabetes will be invited to attend a formal
screening visit. Participants with impaired glucose tolerance defined as 2-hour plasma
glucose 140-199 mg/dl after a fasting 75-g oral glucose tolerance test and who meet
other enrollment criteria will be enrolled.

Exclusion Criteria:

- Type 2 Diabetes (American Diabetes Association Criteria)

- Hypertension with systolic blood pressure (SBP) > 150 mmHg or diastolic blood pressure
(DBP) > 100 mmHg or taking anti-hypertensive medications

- SBP < 100 mmHg or DBP 5.0 milliequivalent/L)

- Abnormal renal function tests: Glomerular Filtration Rate calculated using the Chronic
Kidney Disease Epidemiology Equation 5% over the previous 6 months,

- Pregnancy, planning to conceive a child in the next 9 months, or progesterone
based contraception and unable to switch to non-progesterone based contraception,

- Previous or current diagnosis of cardiac structural and functional abnormalities,
history or current diagnosis of heart failure (New York Heart Association classes
II-IV), history of myocardial infarction, coronary bypass surgery, or
percutaneous coronary intervention during the 6 months prior to screening,

- History of angioedema, or known hypersensitivity to study drugs.

Contacts and Locations
Contacts

Contact: Amber Anaya, BS, CCRC (614) 688-6257 Amber.Anaya@osumc.edu

Locations

United States, Ohio
The Ohio State University Wexner Medical Center
Columbus

Sponsors and Collaborators

Ohio State University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator: Joshua J Joseph, MD The Ohio State University Wexner Medical Center

More Information
  • Responsible Party: Ohio State University
  • ClinicalTrials.gov Identifier: NCT03938389 History of Changes
  • Other Study ID Numbers: 2018H0061, K23DK117041
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: February 20, 2020
  • Last Verified: February 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Ohio State University: African American
    Black
    Prediabetes
    Impaired Glucose Tolerance
  • Additional relevant MeSH terms: Glucose Intolerance Prediabetic State