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Metabolic Syndrome and Fingertip Endothelial Dysfunction

K

Kumamoto University

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Other: Lifestyle instruction

Study type

Interventional

Funder types

Other

Identifiers

NCT01007227
743EndothelialMetsyd

Details and patient eligibility

About

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).

Full 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.

Enrollment

70 patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 1 patient group

Lifestyle instruction
Other group
Treatment:
Other: Lifestyle instruction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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