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NCT03938389Active, not recruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 11 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
90 (estimated)
First submitted
1 May 2019
Start date
25 Feb 2020
Primary completion date
8 Feb 2024
Lead sponsor
Ohio State University
Diseases
Obesity
NCT number
NCT03938389

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 90
  • From 25 Feb 2020 to the primary completion date, 8 Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pharmacologic treatment with statins, β-Blockers, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, renin inhibitors, and/or mineralocorticoid antagonists
  • Steroid use
  • Treatment with oral hypoglycemic medications,
  • 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.

Other illness

  • 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
  • Abnormal renal function tests: Glomerular Filtration Rate calculated using the Chronic Kidney Disease Epidemiology Equation \< 60 ml/min/1.73 m²
  • Use of antipsychotic medications or severe psychiatric disorders (severe mental illness)
    • Severe Psychiatric Disorders:
  • 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
  • Panic disorder
  • Post-traumatic stress disorders (acute, chronic, or with delayed onset)

Lab values

  • Hyperkalemia (Potassium \> 5.0 milliequivalent/L)

Other

  • SBP \< 100 mmHg or DBP \< 60 mmHg
  • Schizophrenia
  • Depression in childhood and adolescence
  • Bulimia Nervosa

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The Ohio State University -Wexner Medical Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.