Clinical trial NCT00946868: Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication
Official title: Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intermittent Claudication
Metabolic Syndrome X
Keywords: intermittent claudication
metabolic syndrome
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-07-27
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients of the Vascular and Endovascular Department (Intermittent Claudicantion Group)

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.

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 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

Primary outcomes:
measure: Presence of metabolic syndrome in patients with intermittent claudication
timeFrame: After laboratory exams results.
Secondary outcomes:
measure: Correlation of metabolic syndrome with age, sex, localization of the arterial obstruction and the association with symptomatic coronary artery disease.
timeFrame: At the end of data collection
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Nelson Wolosker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Pedro P Leao, PhD
role: STUDY_CHAIR
References:
citation: Ambrosetti M, Salerno M, Laporta A, Pedretti RF. Metabolic syndrome in patients with intermittent claudication referred to vascular rehabilitation. Int Angiol. 2006 Mar;25(1):14-7.
citation: Ford ES, Giles WH, Mokdad AH. Increasing prevalence of the metabolic syndrome among u.s. Adults. Diabetes Care. 2004 Oct;27(10):2444-9. doi: 10.2337/diacare.27.10.2444.
citation: Ford ES, Giles WH. A comparison of the prevalence of the metabolic syndrome using two proposed definitions. Diabetes Care. 2003 Mar;26(3):575-81. doi: 10.2337/diacare.26.3.575.
citation: Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA. 2002 Jan 16;287(3):356-9. doi: 10.1001/jama.287.3.356.
citation: Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.
citation: National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.