Assessing the Prevalence of Metabolic Syndrome in Renal Transplantation

NCT01753973 | Completed DMC

• 1 other identifier: CAPPesq 164.096
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Metabolic syndrome; Renal transplantation

Outcome Measures

Primary Outcomes (1)

• To evaluate the prevalence of metabolic syndrome in renal transplant patients.

  12 months

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Elias David-Neto, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Fabiana Agena, MS

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 20, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: December 16, 2015

Record last verified: 2014-06

Locations

BR (1)