Chronic Renal Failure (CRF)NCT01753973
Assessing the Prevalence of Metabolic Syndrome in Renal Transplantation
An observational study of Chronic Renal Failure (CRF) and Renal Transplantation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Renal Failure (CRF), Renal Transplantation
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas - Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-900
About this study
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.
Read the 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.
- Conditions
- Chronic Renal Failure (CRF), Renal Transplantation
- Keywords
- Metabolic syndrome, Renal transplantation
- Medical subject headings
- Kidney Failure, Chronic, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the prevalence of metabolic syndrome in renal transplant patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal Failure (CRF)Studies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elias David-Neto, MD, Principal investigator, University of Sao PauloFabiana Agena, MS, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753973
- Sponsor's protocol ID
- CAPPesq 164.096
- Status last verified
- Jun 2014
- First submitted
- 17 Dec 2012
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Prevalence of Metabolic Syndrome in Renal Transplantation
- ClinicalTrials.gov ID
- NCT01753973
- Acronym / sponsor ID
- CAPPesq 164.096
- Conditions
- Chronic Renal Failure (CRF), Renal Transplantation
- Keywords
- Metabolic syndrome, Renal transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the prevalence of metabolic syndrome in renal transplant patients.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elias David-Neto, MD principal investigator
University of Sao Paulo
Fabiana Agena, MS principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Failure (CRF) and Renal Transplantation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the prevalence of metabolic syndrome in renal transplant patients. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.