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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
1,608 Previous Clinical Trials
11,469,849 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,308 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,468 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why do people often take Hypoglycemia and Spironolactone together?

"Hypoglycemia and Spironolactone is most commonly used to treat primary hyperaldosteronism. It can also be used to manage cirrhosis of the liver, therapeutic procedure, and acne."

Answered by AI

Does this experiment have a minimum age requirement for participants?

"The age limit for this particular trial is 55. If an applicant is too young or too old, there are other medical trials better suited for them. There are 73 clinical trials for patients under the age of 18 and 469 for people over 65."

Answered by AI

Are patients with pre-existing conditions able to join this trial?

"28 individuals are being sought for this clinical trial that necessitates candidates have hypoglycemia and be between 18-55 years old."

Answered by AI

Has the FDA cleared Hypoglycemia and Spironolactone for use?

"Given that this is a Phase 4 trial and the treatment has already been approved, the Power team rates the safety of Hypoglycemia and Spironolactone as a 3."

Answered by AI

Are there any available vacancies in this research program?

"This specific trial is not currently recruiting patients. The trial was initially posted on July 17th, 2013 and was edited on July 18th, 2020. There are 29 other trials for Hypoglycemia and Spironolactone that are looking for patients."

Answered by AI

Are there any other instances where Hypoglycemia and Spironolactone have been looked at together?

"There are currently 29 clinical trials studying the comorbidity of hypoglycemia and spironolactone with 8 of them in Phase 3. While Boston, Massachusetts hosts several of these trials, 293 locations across the globe are running these trials."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Beth Israel Deaconess Medical Center
Recent research and studies
clinicaltrials.govStudy
Hypoglycemia and Autonomic Nervous System Function-B
Gail Kurr Adler 2013. "Hypoglycemia and Autonomic Nervous System Function-B". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03429946.
All > Hypoglycemia
~2 spots leftby Apr 2025
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