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Mineralocorticoid Receptor Antagonist

Medication for Preventing Heart Effects from Low Blood Sugar (HypoANS-B Trial)

Phase 4
Waitlist Available
Led By Roy Freeman, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baroreflex sensitivity is assessed on the 3rd day of each treatment (i.e. about 16 hours after completion of the hyperinsulinemic clamp)
Awards & highlights

HypoANS-B Trial Summary

This trial will test if low blood sugar affects heart function and if a medication can prevent those effects.

Who is the study for?
This trial is for healthy men and women aged 18 to 55 who have not used steroids in the last year, oral contraceptives in the past 3 months, or certain erectile dysfunction drugs within 72 hours. Participants should not have high blood pressure, major depression, kidney issues, or a history of heart disease.Check my eligibility
What is being tested?
The study investigates how low blood sugar affects heart-related nerve functions by comparing two procedures: one that lowers blood sugar and another that keeps it normal. It also examines if Spironolactone (a drug) can prevent these effects versus a placebo.See study design
What are the potential side effects?
Potential side effects may include changes in potassium levels due to Spironolactone, reactions at infusion sites from clamps procedures, and possible cardiovascular responses to the interventions.

HypoANS-B Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~muscle sympathetic nerve activity is assessed on the 3rd day of each treatment (i.e. about 16 hours after completion of the hyperinsulinemic clamp)
This trial's timeline: 3 weeks for screening, Varies for treatment, and muscle sympathetic nerve activity is assessed on the 3rd day of each treatment (i.e. about 16 hours after completion of the hyperinsulinemic clamp) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baroreflex Sensitivity assessed on Day 3
Secondary outcome measures
Muscle sympathetic nerve activity assessed on Day 3

HypoANS-B Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Hypoglycemia and PlaceboActive Control2 Interventions
Participants undergo two 120-minute hypoglycemic hyperinsulinemic clamp procedures (50 mg/dL) - an AM clamp from about 9 am to 11 am and a PM clamp from 1 pm to 3 pm on Day 2 of a 3-Day study visit. Participants receive two doses of placebo - one dose 12 hours and one dose 3 hours before the first clamp starts. Modified Oxford Procedure is performed in duplicate at six time points - on Day 1, before the AM hyperinsulinemic clamp, during the AM hyperinsulinemic clamp, before the PM hyperinsulinemic clamp, during the PM hyperinsulinemic clamp, and on Day 3. The Modified Oxford procedure is performed to calculate baroreflex sensitivity.
Group II: Hypoglycemia and SpironolactoneActive Control2 Interventions
Participants undergo two 120-minute hypoglycemic hyperinsulinemic clamp procedures (50 mg/dL) - an AM clamp from about 9 am to 11 am and a PM clamp from 1 pm to 3 pm on Day 2 of a 3-Day study visit. Participants receive two doses of 100 mg of spironolactone - one dose 12 hours and one dose 3 hours before the first clamp starts. Modified Oxford Procedure is performed in duplicate at six time points - on Day 1, before the AM hyperinsulinemic clamp, during the AM hyperinsulinemic clamp, before the PM hyperinsulinemic clamp, during the PM hyperinsulinemic clamp, and on Day 3. The Modified Oxford procedure is performed to calculate baroreflex sensitivity.
Group III: Euglycemia and PlaceboPlacebo Group2 Interventions
Participants undergo two 120-minute euglycemic hyperinsulinemic clamp procedures (90 mg/dL) - an AM clamp from about 9 am to 11 am and a PM clamp from 1 pm to 3 pm on Day 2 of a 3-Day study visit. Participants receive two doses of placebo - one dose 12 hours and one dose 3 hours before the first clamp starts. Modified Oxford Procedure is performed in duplicate at six time points - on Day 1, before the AM hyperinsulinemic clamp, during the AM hyperinsulinemic clamp, before the PM hyperinsulinemic clamp, during the PM hyperinsulinemic clamp, and on Day 3. The Modified Oxford procedure is performed to calculate baroreflex sensitivity.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,622 Previous Clinical Trials
11,468,729 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
839 Previous Clinical Trials
13,010,398 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,208 Total Patients Enrolled

Media Library

Spironolactone (Mineralocorticoid Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03429946 — Phase 4
Low Blood Sugar Research Study Groups: Hypoglycemia and Placebo, Hypoglycemia and Spironolactone, Euglycemia and Placebo
Low Blood Sugar Clinical Trial 2023: Spironolactone Highlights & Side Effects. Trial Name: NCT03429946 — Phase 4
Spironolactone (Mineralocorticoid Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03429946 — Phase 4
~2 spots leftby May 2025
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