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| Sponsored by: |
Southampton University Hospitals NHS Trust |
|---|---|
| Information provided by: | Southampton University Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00666029 |
Purpose
To characterize features of metabolic syndrome in volunteers. To undertake a randomised trial to determine whether treatment with a statin improves muscle microvascular blood flow.
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome |
Drug: atorvastatin Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Pharmacodynamics Study |
| Official Title: | Implications for Treatment of the Metabolic Syndrome |
| Enrollment: | 40 |
| Study Start Date: | February 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Active arm atorvastatin 40 mg. o.d.
|
Drug: atorvastatin
40 m.g. o.d. tablets for 6 months
|
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2: Placebo Comparator
Placebo arm dummy pill
|
Drug: placebo
Placebo
|
To characterise features of the metabolic syndrome, including body fat, insulin sensitivity, and liver fat together with muscle micorvascular blood flow.
To undertake a randomised controlled trial of atorvastatin 40 mg. o.d for 6 months to determine whether any of the above measures change with treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | 4-2-65 (Version 4. 2007-07-03), 05/Q1704/38, RHM MED 0572 |
| Study First Received: | April 22, 2008 |
| Last Updated: | April 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00666029 |
| Health Authority: | United Kingdom: Research Ethics Committee |
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metabolic syndrome Volunteers recruited from the community |
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Atorvastatin |
|
Antimetabolites Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Syndrome Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |
