Implications for Treatment of the Metabolic Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Atorvastatin

Active arm atorvastatin 40 mg. o.d.

Group Type ACTIVE_COMPARATOR

atorvastatin

Intervention Type DRUG

40 m.g. o.d. tablets for 6 months

Placebo

Placebo arm dummy pill

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo

Interventions

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atorvastatin

40 m.g. o.d. tablets for 6 months

Intervention Type DRUG

placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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Lipitor Dummy

Eligibility Criteria

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Inclusion Criteria

NCEP III ATP metabolic syndrome criteria are:

Waist greater than or equal to 102 cm BP greater than 130 / 85 mmHg TG greater than or equal to 1.7mmol/l Glucose greater than or equal to 6.1 mmol/l HDL less than 1.0 mmol/l

Exclusion Criteria

Aged \<18 years Aged \>75 years Known diabetes; renal, liver, or uncontrolled thyroid disease; uncontrolled hypertension; treatment with lipid-modifying drugs; antihypertensive medication; corticosteroid therapy; or hormone replacement therapy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes