- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01753973
Assessing the Prevalence of Metabolic Syndrome in Renal Transplantation
Study Overview
Status
Conditions
Detailed Description
Metabolic syndrome ( MS) is characterized by the presence of a number of metabolic and hemodynamic disorders such as hypertension (HBP ) , abdominal obesity , dyslipidemia, abnormal glucose metabolism and insulin resistance , resulting in increased cardiovascular morbidity and mortality and the risk for developing type 2 diabetes mellitus.
The concept of metabolic syndrome (MS ) was first described by Reaven in 1988 as a combination of obesity , dyslipidemia , hypertension and fasting hyperglycemia , insulin resistance and inflammation as common pathophysiological disorders in cardiovascular disease (CVD). But the first comprehensive definition of MS was established only in 1998 , the World Health Organization ( WHO ) , in order to facilitate research in this area and points as a key indicator of SM the presence of hyperglycemia and / or resistance to insulin associated with days or more metabolic abnormalities (hypertension, dyslipidemia , obesity, and microalbuminuria).
In the general population , the presence of MS is associated with increased risk of developing diabetes mellitus ( DM ) and cardiovascular disease . Some studies have associated the SM to the appearance of proteinuria and reduction in the value of the glomerular filtration rate ( GFR ), suggesting an association SM with chronic kidney disease ( CKD ) .
Metabolic syndrome (MS) consists of complex disorder that involves assembly cardiovascular risk factors related to abdominal fat deposition and insulin resistance . MS is associated with cardiovascular disease , increasing overall mortality by about 1.5 times and cardiovascular mortality by about 2.5 times.
In 2001 , the National Cholesterol Education Program - Panel of the National Cholesterol Education Program ( NCEP - ATP III ), prepared another proposal. According to the NCEP ATP III, SM represents the combination of at least three components.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sao Paulo, Brazil, 05403-900
- Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 18 and 60
- Both sexes
- Renal transplant recipients Renal Transplant Unit, Hospital das Clinicas, FMUSP living donor or deceased
- Use of immunosuppressive regimen consisting of tacrolimus, mycophenolate sodium and prednisone
Exclusion Criteria:
- Presence of severe disease with reduced life expectancy
- Presence of diabetic nephropathy
- Presence of cardiac arrhythmia which affects the blood pressure measurement
- Patients with BMI ≥ 40 kg / m²
- Calculated creatinine clearance by Cockroft Gault-≤ 40ml/min
- Transplantation of multiple organs or organ transplant prior to any distinct kidney
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the prevalence of metabolic syndrome in renal transplant patients.
Time Frame: 12 months
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12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Elias David-Neto, MD, University of Sao Paulo
- Principal Investigator: Fabiana Agena, MS, University of Sao Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAPPesq 164.096
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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