Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication

Metabolic Syndrome X Clinical Trial

Official title:

Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946868
• Other study ID #: 0143/09
• Status: Completed
• Phase: N/A
• First received: July 23, 2009
• Last updated: July 23, 2009
• Start date: May 2009
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intermittent Claudication
• Metabolic Syndrome X
• Syndrome

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View 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 Cholest — View 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. — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of metabolic syndrome in patients with intermittent claudication		After laboratory exams results.	No
Secondary	Correlation of metabolic syndrome with age, sex, localization of the arterial obstruction and the association with symptomatic coronary artery disease.		At the end of data collection	No