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Assessing the Prevalence of Metabolic Syndrome in Renal Transplantation

NCT01753973 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2015-12-16

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Renal Failure (CRF)
  • Renal Transplantation

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Elias David-Neto, MD · University of Sao Paulo

  • Fabiana Agena, MS · University of Sao Paulo

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01753973 on ClinicalTrials.gov