Assessing the Prevalence of Metabolic Syndrome in Renal Transplantation
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Purpose
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.
| Condition |
|---|
|
Chronic Renal Failure (CRF) Renal Transplantation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Assessing the Prevalence of Metabolic Syndrome in Renal Transplantation |
- To evaluate the prevalence of metabolic syndrome in renal transplant patients. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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
Contacts and Locations| Brazil | |
| Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo | |
| Sao Paulo, Brazil, 05403-900 | |
| Principal Investigator: | Elias David-Neto, MD | University of Sao Paulo |
| Principal Investigator: | Fabiana Agena, MS | University of Sao Paulo |
More Information
No publications provided
| Responsible Party: | University of Sao Paulo General Hospital |
| ClinicalTrials.gov Identifier: | NCT01753973 History of Changes |
| Other Study ID Numbers: | CAPPesq 164.096 |
| Study First Received: | December 17, 2012 |
| Last Updated: | March 11, 2013 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo General Hospital:
|
Metabolic syndrome Renal transplantation |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Renal Insufficiency Metabolic Syndrome X Renal Insufficiency, Chronic Kidney Diseases |
Urologic Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013