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Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00946868
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : July 27, 2009
Information provided by:
University of Sao Paulo

Brief Summary:

Metabolic syndrome, a group of cardiovascular risk factors related to insulin resistance, is a major determinant of cardiovascular mortality.

Intermittent claudication is a symptom of an early stage of atherosclerosis.

The aim of this study is to determine the prevalence of the metabolic syndrome in patients with intermittent claudication and its correlation with age, gender, localization of arterial obstruction and association with coronary artery disease.

Condition or disease
Intermittent Claudication Metabolic Syndrome X

Detailed Description:

Studies correlating metabolic syndrome and several illnesses are being published, especially affections associated with atherosclerosis, like coronary artery disease, cerebrovascular disease and peripheral arterial disease.

The term peripheral arterial disease, however, refers to several stages of the development of atherosclerosis in the extremities, comprising since asymptomatic patients as far as individuals with critical ischemia.

Intermittent claudication is a symptom of an early stage of atherosclerosis, when medical interventions may still prevent the progression of the disease. Despite the importance of a precocious diagnosis of metabolic syndrome to initiate adequate treatment, its prevalence among these patients is not well determined in the literature.

This is the biggest casuistic in the literature as far as we know.

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Study Type : Observational
Actual Enrollment : 170 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication
Study Start Date : May 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Intermittent claudication patients
Patients with intermittent claudication with metabolic syndrome and patients with intermittent claudication without metabolic syndrome.

Primary Outcome Measures :
  1. Presence of metabolic syndrome in patients with intermittent claudication [ Time Frame: After laboratory exams results. ]

Secondary Outcome Measures :
  1. Correlation of metabolic syndrome with age, sex, localization of the arterial obstruction and the association with symptomatic coronary artery disease. [ Time Frame: At the end of data collection ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients of the Vascular and Endovascular Department (Intermittent Claudicantion Group)

Inclusion Criteria:

  • adult patients with complaints compatible with intermittent claudication of the lower limbs, absence or weakness of arterial pulses on the limb or limbs that are limiting deambulation, ankle-brachial index simila or lower than 0.9

Exclusion Criteria:

  • patients with critical limb ischaemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946868

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Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, SP, Brazil, 05403 000
Sponsors and Collaborators
University of Sao Paulo
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Principal Investigator: Nelson Wolosker, PhD University of Sao Paulo
Study Chair: Pedro P Leao, PhD University of Sao Paulo
Publications of Results:
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Responsible Party: Nelson Wolosker, PhD, University of Sao Paulo Identifier: NCT00946868    
Other Study ID Numbers: 0143/09
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: July 27, 2009
Last Verified: July 2009
Keywords provided by University of Sao Paulo:
intermittent claudication
metabolic syndrome
Additional relevant MeSH terms:
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Intermittent Claudication
Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases