Intermittent ClaudicationNCT00946868
Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication
An observational study of Intermittent Claudication and Metabolic Syndrome X, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Claudication, Metabolic Syndrome X
- How many people
- 170 participants
- Where
- 1 siteBrazil
- Study dates
- May 2009to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients of the Vascular and Endovascular Department (Intermittent Claudicantion Group)
Who may be able to join
- 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
Who cannot join
- patients with critical limb ischaemia
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403 000
About this study
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.
Read the 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.
- Conditions
- Intermittent Claudication, Metabolic Syndrome X
- Keywords
- intermittent claudication, metabolic syndrome
- Medical subject headings
- Intermittent Claudication, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent claudication patients | Patients with intermittent claudication with metabolic syndrome and patients with intermittent claudication without metabolic syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of metabolic syndrome in patients with intermittent claudication
Measured: After laboratory exams results.
Secondary outcomes (1)
Correlation of metabolic syndrome with age, sex, localization of the arterial obstruction and the association with symptomatic coronary artery disease.
Measured: At the end of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Nelson Wolosker, PhD, Principal investigator, University of Sao PauloPedro P Leao, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946868
- Sponsor's protocol ID
- 0143/09
- Status last verified
- Jul 2009
- First submitted
- 23 Jul 2009
- Last updated
- 27 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16520719Ford 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.
PubMed 15451914Ford 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.
PubMed 12610004Ford 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.
PubMed 11790215Expert 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.
PubMed 11368702National 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.
PubMed 12485966
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Metabolic Syndrome in Patients With Intermittent Claudication
- ClinicalTrials.gov ID
- NCT00946868
- Acronym / sponsor ID
- 0143/09
- Conditions
- Intermittent Claudication, Metabolic Syndrome X
- Keywords
- intermittent claudication, metabolic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermittent claudication patients | – | –Patients with intermittent claudication with metabolic syndrome and patients with intermittent claudication without metabolic syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients of the Vascular and Endovascular Department (Intermittent Claudicantion Group)
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- patients with critical limb ischaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of metabolic syndrome in patients with intermittent claudication
Time frame: After laboratory exams results.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2009.
- Results publication: PubMed 16520719Ambrosetti 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.
- Results publication: PubMed 15451914Ford 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.
- Results publication: PubMed 12610004Ford 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.
- Results publication: PubMed 11790215Ford 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.
- Results publication: PubMed 11368702Expert 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.
- Results publication: PubMed 12485966National 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.
Related trials for Intermittent Claudication
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Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelson Wolosker, PhD principal investigator
University of Sao Paulo
Pedro P Leao, PhD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intermittent Claudication and Metabolic Syndrome X, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of metabolic syndrome in patients with intermittent claudication (time frame: After laboratory exams results.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00946868, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2009; AzTrials last refreshed its copy on 8 Nov 2026.