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
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.
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 →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.
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Exclusion Criteria:
Severe Psychiatric Disorders:
Anorexia Nervosa
Valsartan 160 mg twice daily for 26 weeks
Drug: Valsartan 160mg
Sacubitril/Valsartan (97/103 mg) twice daily for 26 weeks
Drug: Sacubitril-Valsartan Tab 97-103 MG
placebo (+/- amlodipine 2.5-5 mg twice daily if high blood pressure)
Drug: Placebo Oral Tablet
Participants will take Sacubitril-Valsartan for 26 weeks
Also known as: Entresto
Participant will take Valsartan for 26 weeks
Also known as: Diovan
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)
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
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
Plan to share: No
No publications or documents are linked to this record.
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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Ohio State University