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Metabolic Syndrome and Fingertip Endothelial Dysfunction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Kumamoto University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Kumamoto University
ClinicalTrials.gov Identifier:
NCT01007227
First received: November 2, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

Life-style intervention with dietetic and exercise therapy is an important fundamental approach to patients with metabolic syndrome (MetSyd) which may cause endothelial dysfunction leading to cardiovascular events. We investigated whether the life-style modification by dietetic and exercise instruction could improve endothelial dysfunction assessed by a new non-invasive and automatic device; digital reactive hyperemia peripheral arterial tonometry (RH-PAT).


Condition Intervention Phase
Metabolic Syndrome
 Other: Lifestyle instruction
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Achievement of Dietetic and Exercise Therapy Evaluated by Self-assessment Score Significantly Improved Endothelial Dysfunction in Patients With Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • Endothelial function assessed by RH-PAT [ Time Frame: About 1 year later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metabolic status including waist circumference [ Time Frame: About 1 year later ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: August 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lifestyle instruction Other: Lifestyle instruction
Instruction dietetic and exercise therapy

Detailed Description:

Outline of methods RH-PAT was measured in high-risk patients under 70 years old. The MetSyd was defined according to guidelines of the National Cholesterol Education Program Third Adult Treatment Panel (NCEP - ATP III). We instructed all MetSyd patients about the dietetic and exercise therapy according to the Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases. we conducted a questionnaire survey of the self-assessment for dietetic and exercise instruction program, respectively.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Under 70 years old and preserved left ventricular systolic function (left ventricular ejection fraction ≥ 50%)

Exclusion Criteria:

  • Severe valvular heart disease
  • Atrial septal defect
  • Myocarditis
  • Cardiomyopathy
  • Active inflammatory diseases
  • Pulmonary hypertension
  • Chronic kidney disease on hemodialysis
  • Advanced hepatic disease
  • Leukemia
  • Schizophrenia; AND
  • Cerebrovascular disease and residual hemiplegia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007227

Locations
Japan
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
  More Information

No publications provided

Responsible Party: Seigo Sugiyama, Department of Cardiovascular Medicine, Kumamoto University
ClinicalTrials.gov Identifier: NCT01007227     History of Changes
Other Study ID Numbers: 743EndothelialMetsyd
Study First Received: November 2, 2009
Last Updated: November 2, 2009
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013