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
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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized prospective controlled clinical trial with three parallel arms, no crossover.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Valsartan
Valsartan 160 mg twice daily for 26 weeks
Drug: Valsartan 160mg
Participant will take Valsartan for 26 weeks
Other Name: Diovan
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.
- 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.
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|