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NCT01103245 · ClinicalTrials.gov registry record · Phase 1
Aldosterone and the Metabolic Syndrome
A Phase 1 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
NCT01103245: Completed Phase 1 study, sponsored by Vanderbilt University Medical Center.
NCT01103245 is a Phase 1 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01103245, a Phase 1 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on glucose metabolism in humans.
Primary Outcome
A Hyperglycemic clamp was performed once during each study period to assess glucose stimulated insulin secretion. Glucose is infused intravenously to maintain blood glucose near 200 mg/dL to stimulate insulin secretion. During this time plasma insulin levels were measured and the insulin response is reported as the incremental increase over the first 10 minutes of glucose administration.
Interventions
- DRUG Hydrochlorothiazide (HCTZ)
- DRUG Aliskiren 150 mg (ALI 150)
- DRUG Spironolactone (SPL 25)
- DRUG Aliskiren 300 mg (ALI 300)
- DRUG Spironolactone 50 mg (SPL 50)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2010-03 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
What the finished NCT01103245 record still lists
NCT01103245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 5 interventions - of which Hydrochlorothiazide (HCTZ) is the first listed.
NCT01103245 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01103245 about?
NCT01103245 is a clinical study titled "Aldosterone and the Metabolic Syndrome". The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on glucose metabolism in humans.
What is the current status of trial NCT01103245?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2010-03. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01103245?
The interventions under investigation include: Hydrochlorothiazide (HCTZ) (DRUG), Aliskiren 150 mg (ALI 150) (DRUG), Spironolactone (SPL 25) (DRUG), Aliskiren 300 mg (ALI 300) (DRUG), Spironolactone 50 mg (SPL 50) (DRUG).
Who is sponsoring clinical trial NCT01103245?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01103245's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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