Sacubitril-Valsartan for Prediabetes

Palo Alto (17 mi)

Overseen byJoshua J Joseph, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Ohio State University

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for African Americans aged 18-65 with prediabetes or risk factors like a family history of type 2 diabetes. It's not for those with type 2 diabetes, recent significant weight loss, certain heart conditions, abnormal kidney function, severe psychiatric disorders, pregnancy or specific medication use.

Exclusion Criteria

My kidney function is below normal levels.

I have had, or plan to have, weight loss surgery.

I have been diagnosed with Type 2 Diabetes.

I have lost more than 5% of my weight in the last 6 months.

I am not on antipsychotic medication and do not have a severe psychiatric disorder.

I have high blood pressure or I am on medication for it.

I am taking oral medication for diabetes.

Treatment Details

The study tests the effects of RAAS blockade (Valsartan) and combined RAAS/neprilysin inhibition (Sacubitril-Valsartan) versus placebo on blood sugar control and insulin release in African Americans with impaired glucose tolerance over a period of 26 weeks.

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Sacubitril/ValsartanExperimental Treatment1 Intervention

Sacubitril/Valsartan (97/103 mg) twice daily for 26 weeks

Group II: ValsartanActive Control1 Intervention

Valsartan 160 mg twice daily for 26 weeks

Group III: PlaceboPlacebo Group1 Intervention

placebo (+/- amlodipine 2.5-5 mg twice daily if high blood pressure)