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NCT01252238 · ClinicalTrials.gov registry record · NA
Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance
A NA study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT01252238 is a NA study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 24 participants.
The verdict
NCT01252238, a NA study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study is an investigation of the effect of commonly prescribed anti-hypertensive agents on insulin sensitivity, diastolic function and aortic compliance. The aims of the study are as follows: Specific Aim 1: To determine in insulin resistant, hypertensive subjects if renin inhibition for 12 weeks modifies glucose homeostasis and insulin sensitivity. To accomplish this specific aim, we will use three approaches: a fasting HOMA Index; and a three hour glucose tolerance test. Only hypertensive subjects with insulin resistance, as assessed by HOMA index will be enrolled in the study. Insulin resistance will be assessed basally and after twelve weeks of treatment with either a calcium channel blocker with placebo, or calcium channel blocker with a renin inhibitor, or a calcium channel blocker with a renin inhibitor and an angiotensin receptor antagonist. Specific Aim 2: To determine in insulin resistant, hypertensive subjects if renin inhibition for 12 weeks modifies diastolic function and aortic compliance response to dietary sodium intake. The same protocol and subjects will be used as defined in Specific Aim 1. Myocardial relaxation velocity (tissue Doppler imaging at the mitral annulus) and aortic compliance (characteristic aortic impedance) will be measured at baseline and then after acute and chronic renin inhibition: 1. Acute effect of renin inhibition: Hemodynamic measurements will be obtained on both high and low dietary sodium intake conditions (\~1 week each) before and after a single dose of a renin inhibitor. 2. Chronic effect of renin inhibition: Hemodynamic measurements will be obtained at baseline and after 12 weeks of each of the three drug treatment arms above. The study lasts 12 weeks and plans to study 45 hypertensive adults over the next two years.
Interventions
- DRUG Amlodipine
- DRUG Aliskiren
- DRUG Valsartan and Aliskiren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01252238
The ClinicalTrials.gov registry entry for NCT01252238 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Amlodipine is the first listed.
NCT01252238 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01252238 about?
NCT01252238 is a clinical study titled "Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance". This study is an investigation of the effect of commonly prescribed anti-hypertensive agents on insulin sensitivity, diastolic function and aortic compliance. The aims of the study are as follows: Specific Aim 1: To determine in insulin resistant, hypertensive subjects if renin inhibition for 12 we...
What is the current status of trial NCT01252238?
This trial is currently terminated. It is a NA study. The enrollment target is 24 participants. The study started on 2010-06. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01252238?
The interventions under investigation include: Amlodipine (DRUG), Aliskiren (DRUG), Valsartan and Aliskiren (DRUG).
Who is sponsoring clinical trial NCT01252238?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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