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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014