Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Assessing the Prevalence of Metabolic Syndrome in Renal Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Sao Paulo General Hospital
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01753973
First received: December 17, 2012
Last updated: June 5, 2014
Last verified: June 2014

December 17, 2012
June 5, 2014
January 2013
December 2014   (final data collection date for primary outcome measure)
To evaluate the prevalence of metabolic syndrome in renal transplant patients. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The determination of the metabolic syndrome at 6 months predicts this same condition at 12 months. [ Time Frame: After 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01753973 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Assessing the Prevalence of Metabolic Syndrome in Renal Transplantation
Assessing the Prevalence of Metabolic Syndrome in Renal Transplantation

Metabolic syndrome (MS) is characterized by a series of metabolic and hemodynamic parameters such as hypertension (hypertension), 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 (T2DM). Metabolic syndrome is a common event after renal transplantation. The prevalence of MS increases post-transplant with weight gain. In renal transplant recipients, the SM is associated with CVD, diabetes after transplantation, worsening renal function and graft loss. Immunosuppressant medications have primary effect on the pathophysiology of MS. Several studies have evaluated the prevalence and impact of metabolic syndrome in renal transplant recipients as obesity, hypertension, dyslipidemia and use of immunosuppressants. The objectives of this study are to determine whether the determination of the metabolic syndrome at 6 months predicts this same condition at 12 months, determine the prevalence of metabolic syndrome at 12 months, to assess the prevalence of obesity and overweight in this population and to assess the prevalence of diabetes mellitus after renal transplantation. Patients who meet the inclusion criteria and did not meet the exclusion criteria will be invited to participate in the study, signing the Instrument of Consent (IC) and informed about the objectives and procedures of the study to be performed, with age between 18 and 60 years, both sexes, renal transplant recipients Renal Transplant Unit, Hospital das Clinicas, FMUSP living donor or deceased and use of immunosuppressive regimen consisting of tacrolimus, mycophenolate sodium and prednisone. Sampling will be conducted laboratory tests, filling out questionnaires on quality of life and anthropometric measures.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients will be selected by examining the clinical records of Renal Transplant Service, Hospital das Clinicas, Faculty of Medicine, University of São Paulo (HCFMUSP). Patients who meet the inclusion criteria and did not meet the exclusion criteria will be invited to participate in the study, signing the Instrument of Consent (IC) and informed about the objectives and procedures of the study to be performed.

  • Chronic Renal Failure (CRF)
  • Renal Transplantation
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Elias David-Neto, MD 55-11-2661-8089 elias.david.neto@attglobal.net
Contact: Fabiana Agena, MS 55-11-2661-8089 pesquisaclinicautr.ichc@hc.fm.usp.br
Brazil
 
NCT01753973
CAPPesq 164.096
Yes
University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Not Provided
Principal Investigator: Elias David-Neto, MD University of Sao Paulo
Principal Investigator: Fabiana Agena, MS University of Sao Paulo
University of Sao Paulo General Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP