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Active, not recruitingNCT03938389Updated Aug 11, 2025

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

A Phase 4 interventional study of Sacubitril-Valsartan Tab 97-103 MG and Valsartan 160mg in PreDiabetes, Impaired Glucose Tolerance and Obesity, sponsored by Ohio State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Ohio State University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • PreDiabetes
  • Impaired Glucose Tolerance
  • Obesity
  • Blood Pressure

Keywords

  • African American
  • Black
  • Prediabetes
  • Impaired Glucose Tolerance
03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's planned enrollment of 90 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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 \< 60 mmHg
  • Pharmacologic treatment with statins, β-Blockers, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, renin inhibitors, and/or mineralocorticoid antagonists
  • Steroid use
  • Hyperkalemia (Potassium > 5.0 milliequivalent/L)
  • Abnormal renal function tests: Glomerular Filtration Rate calculated using the Chronic Kidney Disease Epidemiology Equation \< 60 ml/min/1.73 m²
  • Treatment with oral hypoglycemic medications,
  • Use of antipsychotic medications or severe psychiatric disorders (severe mental illness)

Severe Psychiatric Disorders:

  • Schizophrenia
  • Paranoid and other psychotic disorders
  • Bipolar disorders (hypomanic, manic, depressive, and mixed)
  • Major depressive disorders (single episode or recurrent)
  • Schizoaffective disorders (bipolar or depressive)
  • Pervasive developmental disorders
  • Obsessive-compulsive disorders
  • Depression in childhood and adolescence
  • Panic disorder
  • Post-traumatic stress disorders (acute, chronic, or with delayed onset)
  • Bulimia Nervosa
  • Anorexia Nervosa

    • History of, or planned, bariatric surgery,
    • Weight loss > 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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Valsartan

    Valsartan 160 mg twice daily for 26 weeks

    Drug: Valsartan 160mg

  • Experimental
    Sacubitril/Valsartan

    Sacubitril/Valsartan (97/103 mg) twice daily for 26 weeks

    Drug: Sacubitril-Valsartan Tab 97-103 MG

  • Placebo comparator
    Placebo

    placebo (+/- amlodipine 2.5-5 mg twice daily if high blood pressure)

    Drug: Placebo Oral Tablet

Interventions

  • DrugSacubitril-Valsartan Tab 97-103 MG

    Participants will take Sacubitril-Valsartan for 26 weeks

    Also known as: Entresto

  • DrugValsartan 160mg

    Participant will take Valsartan for 26 weeks

    Also known as: Diovan

  • DrugPlacebo Oral Tablet

    Participant with take placebo for 26 weeks or if blood pressure elevated will receive standard of care blood pressure medication, amlodipine.

06

What researchers measure

Primary outcomes

  1. Change from Baseline to 26 weeks in β-cell function (first-phase insulin secretion)

    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

Secondary outcomes

  1. Change in Central Aortic Pressure (mmHg) from Baseline to 26 weeks

    Central Aortic Pressure, measured via a non-invasive method using the SphygmoCor XCEL device, in mmHg.

    Time frame: 26 weeks

07

Study locations

1 site
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03938389
Lead sponsor
Ohio State University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Joshua Joseph, MD (Assistant Professor of Medicine, Ohio State University) — Principal investigator
First posted
May 6, 2019
Start date
Feb 25, 2020
Primary completion
Feb 8, 2024
Completion
Jun 2026 (estimated)
Last update
Aug 11, 2025

Study contacts

Joshua J Joseph, MD
principal investigator · Ohio State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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