Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00946868
First received: July 23, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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
Intermittent Claudication
Metabolic Syndrome X

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Presence of metabolic syndrome in patients with intermittent claudication [ Time Frame: After laboratory exams results. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Intermittent claudication patients
Patients with intermittent claudication with metabolic syndrome and patients with intermittent claudication without metabolic syndrome.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients of the Vascular and Endovascular Department (Intermittent Claudicantion Group)

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00946868

Locations
Brazil
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
Investigators
Principal Investigator: Nelson Wolosker, PhD University of Sao Paulo
Study Chair: Pedro P Leao, PhD University of Sao Paulo
  More Information

Publications:
Responsible Party: Nelson Wolosker, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00946868     History of Changes
Other Study ID Numbers: 0143/09
Study First Received: July 23, 2009
Last Updated: July 23, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
intermittent claudication
metabolic syndrome

Additional relevant MeSH terms:
Intermittent Claudication
Metabolic Syndrome X
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 23, 2014