NCT01007227

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 26, 2013

Status Verified

September 1, 2013

Enrollment Period

5.3 years

First QC Date

November 2, 2009

Last Update Submit

September 25, 2013

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Endothelial function assessed by RH-PAT

    About 1 year later

Secondary Outcomes (1)

  • Metabolic status including waist circumference

    About 1 year later

Study Arms (1)

Lifestyle instruction

OTHER
Other: Lifestyle instruction

Interventions

Lifestyle instructionOTHER

Instruction dietetic and exercise therapy

Lifestyle instruction

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kumamoto University Hospital

Kumamoto, Kumamoto, 860-8556, Japan

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 2, 2009

First Posted

November 3, 2009

Study Start

August 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 26, 2013

Record last verified: 2013-09

Locations

JP(1)