Implications for Treatment of the Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier:
NCT00666029
First received: April 22, 2008
Last updated: June 17, 2013
Last verified: June 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Implications for Treatment of the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University Hospital Southampton NHS Foundation Trust.:

Primary Outcome Measures:
  • Effect of atorvastatin 40 mg. o.d on muscle microvascular function and insulin sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • relationships between features of the metabolic syndrome, fitness, insulin sensitivity and microvascular function [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
Experimental: 1
Active arm atorvastatin 40 mg. o.d.
Drug: atorvastatin
40 m.g. o.d. tablets for 6 months
Placebo Comparator: 2
Placebo arm dummy pill
Drug: placebo
Placebo

Detailed Description:

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
Criteria

Inclusion Criteria:

  • NCEP III ATP metabolic syndrome criteria

Exclusion Criteria:

  • Aged <18 years
  • >75 years
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier: NCT00666029     History of Changes
Other 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: June 17, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University Hospital Southampton NHS Foundation Trust.:
metabolic syndrome
Volunteers recruited from the community

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014