The Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose in African Americans
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ClinicalTrials.gov Identifier: NCT03938389 |
Recruitment Status :
Recruiting
First Posted : May 6, 2019
Last Update Posted : February 20, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
PreDiabetes Impaired Glucose Tolerance Obesity Blood Pressure | Drug: Sacubitril-Valsartan Tab 97-103 MG Drug: Valsartan 160mg Drug: Placebo Oral Tablet | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
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) |
Masking Description: | Blinding |
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 25, 2020 |
Estimated Primary Completion Date : | August 2021 |
Estimated Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Valsartan
Valsartan 160 mg twice daily for 26 weeks
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Drug: Valsartan 160mg
Participant will take Valsartan for 26 weeks
Other Name: Diovan |
Experimental: Sacubitril/Valsartan
Sacubitril/Valsartan (97/103 mg) twice daily for 26 weeks
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Drug: Sacubitril-Valsartan Tab 97-103 MG
Participants will take Sacubitril-Valsartan for 26 weeks
Other Name: Entresto |
Placebo Comparator: Placebo
placebo (+/- amlodipine 2.5-5 mg twice daily if high blood pressure)
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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. |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938389
Contact: Amber Anaya, BS, CCRC | (614) 688-6257 | Amber.Anaya@osumc.edu |
United States, Ohio | |
The Ohio State University Wexner Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Amber Anaya, BS, CCRCLPN 614-688-6257 Amber.Anaya@osumc.edu | |
Principal Investigator: Joshua J Joseph, MD |
Principal Investigator: | Joshua J Joseph, MD | The Ohio State University Wexner Medical Center |
Responsible Party: | Joshua Joseph, MD, Assistant Professor of Medicine, Ohio State University |
ClinicalTrials.gov Identifier: | NCT03938389 |
Other Study ID Numbers: |
2018H0061 K23DK117041 ( U.S. NIH Grant/Contract ) |
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 |
African American Black Prediabetes Impaired Glucose Tolerance |
Prediabetic State Glucose Intolerance Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperglycemia |
Valsartan LCZ 696 Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |