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Sacubitril-Valsartan for Prediabetes
Phase 4
Waitlist Available
Led By Joshua J Joseph, MD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Abnormal renal function tests: Glomerular Filtration Rate calculated using the Chronic Kidney Disease Epidemiology Equation < 60 ml/min/1.73 m²
History of, or planned, bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
Summary
This trial is testing whether two drugs, valsartan and sacubitril, can improve blood sugar and insulin secretion better than valsartan alone in African Americans with impaired glucose tolerance.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include dizziness due to low blood pressure, high potassium levels which can affect heart rhythm, kidney problems that may alter how the body cleans the blood, and allergic reactions if sensitive to the drugs.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is below normal levels.
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I have had, or plan to have, weight loss surgery.
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I have been diagnosed with Type 2 Diabetes.
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I have lost more than 5% of my weight in the last 6 months.
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I am not on antipsychotic medication and do not have a severe psychiatric disorder.
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I have high blood pressure or I am on medication for it.
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I am taking oral medication for diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Structure of beta Cell of islet
Secondary study objectives
Change in Central Aortic Pressure (mmHg) from Baseline to 26 weeks
Trial Design
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)
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
859 Previous Clinical Trials
642,675 Total Patients Enrolled
23 Trials studying Obesity
3,884 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,801 Total Patients Enrolled
459 Trials studying Obesity
589,460 Patients Enrolled for Obesity
Joshua J Joseph, MDPrincipal InvestigatorThe Ohio State University Wexner Medical Center
2 Previous Clinical Trials
172 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood potassium level is higher than 5.0 milliequivalent/L.My kidney function is below normal levels.I have had heart problems or surgery in the last 6 months.You have a specific level of high blood sugar after drinking a sugary drink.I have had, or plan to have, weight loss surgery.I have been diagnosed with Type 2 Diabetes.I am African American, aged 18-65, with a history or risk factors for 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.Your blood pressure is lower than 100 over 60.I am taking medication for heart or blood pressure issues.I have high blood pressure or I am on medication for it.I am currently taking steroids.I am taking oral medication for diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Valsartan
- Group 2: Sacubitril/Valsartan
- Group 3: Placebo
Awards:
This trial has 4 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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