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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03938389
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Joshua Joseph, MD, Ohio State University

Study Description
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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 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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Valsartan
Valsartan 160 mg twice daily for 26 weeks
 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
 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)
 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
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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
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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
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 < 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.
Contacts and Locations
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Information from the National Library of Medicine

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


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

Locations
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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         
Sponsors and Collaborators
Ohio State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Joshua J Joseph, MD The Ohio State University Wexner Medical Center
More Information
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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

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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 Joshua Joseph, MD, Ohio State University:
African American
Black
Prediabetes
Impaired Glucose Tolerance
Additional relevant MeSH terms:
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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