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NCT03429946 · ClinicalTrials.gov registry record · Phase 4

Hypoglycemia and Autonomic Nervous System Function-B

A Phase 4 study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
Phase 4
Development phase
28
Enrollment target

NCT03429946: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.

NCT03429946 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03429946, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
Phase 4
Development phase
28 participants
Enrollment target

Study Summary

This study tests the hypothesis that, compared to prior normal blood sugar, prior low blood sugar impairs cardiovascular autonomic function. The proposed studies will also test the hypothesis that the effects of prior low blood sugar on cardiovascular autonomic function are blocked by administration of a mineralocorticoid receptor antagonist.

Primary Outcome

Comparison of Day 3 baroreflex sensitivity (milliseconds/mm Hg) assessed during Hypoglycemic hyperinsulinemic clamp + Placebo treatment as compared to Hypoglycemic hyperinsulinemic clamp + Spironolactone treatment.

Interventions

  • DRUG Placebo
  • DRUG Spironolactone
  • OTHER Hypoglycemic Hyperinsulinemic Clamp
  • OTHER Euglycemic Hyperinsulinemic Clamp

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2013-07-17
Est. Completion 2025-11-25
Phase Phase 4
Brigham and Women's Hospital

937 total trials

What the finished NCT03429946 record still lists

NCT03429946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT03429946 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03429946 about?

NCT03429946 is a clinical study titled "Hypoglycemia and Autonomic Nervous System Function-B". This study tests the hypothesis that, compared to prior normal blood sugar, prior low blood sugar impairs cardiovascular autonomic function. The proposed studies will also test the hypothesis that the effects of prior low blood sugar on cardiovascular autonomic function are blocked by administration...

What is the current status of trial NCT03429946?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2013-07-17. Estimated completion is 2025-11-25.

What interventions are being tested in trial NCT03429946?

The interventions under investigation include: Placebo (DRUG), Spironolactone (DRUG), Hypoglycemic Hyperinsulinemic Clamp (OTHER), Euglycemic Hyperinsulinemic Clamp (OTHER).

Who is sponsoring clinical trial NCT03429946?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03429946's enrollment target sits among peer trials

28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03429946, the US trial registry maintained by the National Library of Medicine. NCT03429946 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.