Diabetes Mellitus Nos New OnsetNCT01976689
New-onset Diabetes and Left Ventricular Hypertrophy in Renal Transplantation
An observational study of Diabetes Mellitus Nos New Onset and Hypertrophy, Left Ventricular, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
New-onset diabetes (NODAT) after solid organ transplantation is an important clinical challenge associated to increased risk of cardiovascular (CV) events. In end-stage renal disease (ESRD) patients, the impact of arterial stiffness on all-cause and CV mortality has been clearly documented. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus Nos New Onset, Hypertrophy, Left Ventricular, Vascular Stiffness
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2012to Sep 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between years 2007-2010, 63 patients were diagnosed as NODAT in our transplantation center from the total 267 patients who underwent renal transplantation. Among these, 159 kidney transplant recipients were selected.
Who may be able to join
- Patients who underwent renal transplantation between years 2007-2010 in our transplantation clinic with routine periodical follow-up.
Who cannot join
- irregular drug usage or patient incompliance
- lack of regular follow-up data
- pretransplant diabetes mellitus history
- bone marrow transplant or other solid organs before or at the time of transplantation (including previous kidney transplantation)
- malign disease, rheumatologic or chronic inflammatory disease of unknown origin, systemic vasculitis history
- acute rejection periods after the first year of transplantation
Show all 12Show fewer
- unstable cardiac disease including heart failure (ejection fraction < %50) and/or ischemic heart disease history (myocardial infarction, need for cardiac revascularization)
- atrial fibrillation or elevated heart rate (>100 beats/min)
- coronary bypass before or after transplantation
- transiently elevated fasting plasma glucose (FPG) or diabetic blood glucose profile during the first 3 posttransplant months
- graft failure [glomerular filtration (GFR) rate < 30 mL/min]
- history of peritoneal dialysis before transplantation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Medical School
Ankara, 06490
About this study
Official title: New- Onset Diabetes and Glucose Regulation Are Significant Determinants of Left Ventricular Hypertrophy in Renal Transplant Recipients
New-onset diabetes (NODAT) after solid organ transplantation is an important clinical challenge associated to increased risk of cardiovascular (CV) events. In end-stage renal disease (ESRD) patients, the impact of arterial stiffness on all-cause and CV mortality has been clearly documented. Arterial stiffness has a pivotal role in the genesis of high blood pressure (SBP), increased left ventricular hypertrophy (LVH), and consequently CV mortality. Both LVH and arterial stiffness are independent determinants of CV disease in patients with ESRD. The aim of this study is to evaluate the relationship between post-transplant new-onset diabetes and arterial stiffness and left ventricular mass index (LVMI) in kidney transplant recipients.
Read the detailed description
All patients' data were recorded from clinical charts. Visits in out patient clinic were organized as follows: three visits per week during the first 2 weeks; two visits per week until day 60; weekly visits until day 120; monthly visits during the first year; one visit every other month during the second year; and four visits per year thereafter until death or end-stage renal disease (i.e. dialysis or retransplantation). The following parameters were collected; 1) age, 2) gender, 3) posttransplantation duration, 4) pretransplant hemodialysis duration, 4) acute rejection episodes, 5) use of statins, ace inhibitor (ACE) or angiotensin receptor blocker (ARB), 6) immunosuppressive treatment (mycophenolate, cyclosporine, tacrolimus, and sirolimus use), 7) pretransplant lipid profile (values in the last month before transplantation), 8) posttransplant lipid profile (mean value), 9) FPG and HbA1c levels (mean value), 10) office blood pressure measurements, 11) hemoglobin, calcium, phosphorus, albumine and parathyroid hormone levels, 12) creatinine and estimated GFR (MDRD equation) and, 13) cytomegalovirus (CMV) infection history. Mean values were arithmetic means of each parameter that were collected from patient charts at 3 monthly basis after the first posttransplant 6 months while other parameters (12-16) were collected as single values at study inclusion.
All patients were under 5 mg prednisolone treatment within the immuno suppressive regimen. Maintenance immunosuppressive treatment included prednisone with a gradual tapering and mycophenolate mofetil or sodium associated with cyclosporine, tacrolimus or sirolimus in most patients. Target through levels at 3 months were 150-250 ng/ml for cyclosporine and 8-12 ng/ml for tacrolimus and sirolimus. Anti-diabetic treatment modalities (diet and lifestyle changes, oral anti-diabetic drugs or insulin) were also recorded for patients with NODAT.
Body compositions of all patients were analyzed by using the Body Composition Analyzer (Tanita BC-420MA). Fat mass, fat free mass, muscle mass, visceral fat mass and body mass index were calculated for each patient.
All patients underwent echocardiographic examinations (Siemens Acuson C256, Mountain view, California 2000 with 3V2c transducer probe) by the same operator and left ventricular mass was calculated according to the Devereux formula and indexed to body surface area to give LVMI (g/m2). Left ventricular mass index values greater than 130g/m2 (n: 57) were defined as high left ventricular mass.
Pulse wave velocity (PWv) is defined as the velocity of the arterial pulse for moving along the vessel wall. Pulse wave velocity along the aorta was measured by using two ultrasound or pressure sensitive transducers fixed transcutaneously over the course of a pair of arteries separated by a known distance: the femoral and right common carotid arteries. PWV was calculated from measurements of pulse transit time and the distance, according to the following formula: PWV (m/s)= distance (m)/transit time (s). Measurement of PWV values was con-ducted after abstinence from caffeine or smoking and after an overnight fast without intake of antihypertensive drugs. PWV was determined by using the SphygmoCor CvMs V9 system and values > 7 m/s was defined as increased.
- Keywords
- Glucose Regulation, Left Ventricular Hypertrophy, New-onset Diabetes, Renal Transplantation
- Medical subject headings
- Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with New-onset Diabetes | New-onset diabetes after transplantation was defined as a fasting plasma glucose (FPG) level ≥ 126 mg/dL (7 mmol/L) or symptoms of diabetes plus casual plasma glucose concentrations ≥200 mg/dL (11.1 mmol/L), confirmed by repeat testing on a different day. According to these criteria, 63 patients were diagnosed as NODAT between years 2007-2010 but after the exclusion criteria of our study 57 patients with and 102 patients without NODAT were included in the study. | |
| Patients without NODAT | New-onset diabetes after transplantation was defined as a fasting plasma glucose (FPG) level ≥ 126 mg/dL (7 mmol/L) or symptoms of diabetes plus casual plasma glucose concentrations ≥200 mg/dL (11.1 mmol/L), confirmed by repeat testing on a different day. According to these criteria, 63 patients were diagnosed as NODAT between years 2007-2010 but after the exclusion criteria of our study 57 patients with and 102 patients without NODAT were included in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular hypertrophy
Measured: 3 years follow-up after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Nos New OnsetStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap Erkmen Uyar, Baskent University
- Investigators
- Siren Sezer, Prof. Dr., Study chair, Baskent University, Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976689
- Sponsor's protocol ID
- TIBU009158
- Status last verified
- Nov 2013
- First submitted
- 30 Oct 2013
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New- Onset Diabetes and Glucose Regulation Are Significant Determinants of Left Ventricular Hypertrophy in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT01976689
- Acronym / sponsor ID
- TIBU009158
- Keywords
- Glucose Regulation, Left Ventricular Hypertrophy, New-onset Diabetes, Renal Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 Nov 2013 (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.
New-onset diabetes (NODAT) after solid organ transplantation is an important clinical challenge associated to increased risk of cardiovascular (CV) events. In end-stage renal disease (ESRD) patients, the impact of arterial stiffness on all-cause and CV mortality has been clearly documented. Arterial stiffness has a pivotal role in the genesis of high blood pressure (SBP), increased left ventricular hypertrophy (LVH), and consequently CV mortality. Both LVH and arterial stiffness are independent determinants of CV disease in patients with ESRD. The aim of this study is to evaluate the relationship between post-transplant new-onset diabetes and arterial stiffness and left ventricular mass index (LVMI) in kidney transplant recipients.
Detailed description
All patients' data were recorded from clinical charts. Visits in out patient clinic were organized as follows: three visits per week during the first 2 weeks; two visits per week until day 60; weekly visits until day 120; monthly visits during the first year; one visit every other month during the second year; and four visits per year thereafter until death or end-stage renal disease (i.e. dialysis or retransplantation). The following parameters were collected; 1) age, 2) gender, 3) posttransplantation duration, 4) pretransplant hemodialysis duration, 4) acute rejection episodes, 5) use of statins, ace inhibitor (ACE) or angiotensin receptor blocker (ARB), 6) immunosuppressive treatment (mycophenolate, cyclosporine, tacrolimus, and sirolimus use), 7) pretransplant lipid profile (values in the last month before transplantation), 8) posttransplant lipid profile (mean value), 9) FPG and HbA1c levels (mean value), 10) office blood pressure measurements, 11) hemoglobin, calcium, phosphorus, albumine and parathyroid hormone levels, 12) creatinine and estimated GFR (MDRD equation) and, 13) cytomegalovirus (CMV) infection history. Mean values were arithmetic means of each parameter that were collected from patient charts at 3 monthly basis after the first posttransplant 6 months while other parameters (12-16) were collected as single values at study inclusion.
All patients were under 5 mg prednisolone treatment within the immuno suppressive regimen. Maintenance immunosuppressive treatment included prednisone with a gradual tapering and mycophenolate mofetil or sodium associated with cyclosporine, tacrolimus or sirolimus in most patients. Target through levels at 3 months were 150-250 ng/ml for cyclosporine and 8-12 ng/ml for tacrolimus and sirolimus. Anti-diabetic treatment modalities (diet and lifestyle changes, oral anti-diabetic drugs or insulin) were also recorded for patients with NODAT.
Body compositions of all patients were analyzed by using the Body Composition Analyzer (Tanita BC-420MA). Fat mass, fat free mass, muscle mass, visceral fat mass and body mass index were calculated for each patient.
All patients underwent echocardiographic examinations (Siemens Acuson C256, Mountain view, California 2000 with 3V2c transducer probe) by the same operator and left ventricular mass was calculated according to the Devereux formula and indexed to body surface area to give LVMI (g/m2). Left ventricular mass index values greater than 130g/m2 (n: 57) were defined as high left ventricular mass.
Pulse wave velocity (PWv) is defined as the velocity of the arterial pulse for moving along the vessel wall. Pulse wave velocity along the aorta was measured by using two ultrasound or pressure sensitive transducers fixed transcutaneously over the course of a pair of arteries separated by a known distance: the femoral and right common carotid arteries. PWV was calculated from measurements of pulse transit time and the distance, according to the following formula: PWV (m/s)= distance (m)/transit time (s). Measurement of PWV values was con-ducted after abstinence from caffeine or smoking and after an overnight fast without intake of antihypertensive drugs. PWV was determined by using the SphygmoCor CvMs V9 system and values > 7 m/s was defined as increased.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with New-onset Diabetes | – | –New-onset diabetes after transplantation was defined as a fasting plasma glucose (FPG) level ≥ 126 mg/dL (7 mmol/L) or symptoms of diabetes plus casual plasma glucose concentrations ≥200 mg/dL (11.1 mmol/L), confirmed by repeat testing on a different day. According to these criteria, 63 patients were diagnosed as NODAT between years 2007-2010 but after the exclusion criteria of our study 57 patients with and 102 patients without NODAT were included in the study. |
| Patients without NODAT | – | –New-onset diabetes after transplantation was defined as a fasting plasma glucose (FPG) level ≥ 126 mg/dL (7 mmol/L) or symptoms of diabetes plus casual plasma glucose concentrations ≥200 mg/dL (11.1 mmol/L), confirmed by repeat testing on a different day. According to these criteria, 63 patients were diagnosed as NODAT between years 2007-2010 but after the exclusion criteria of our study 57 patients with and 102 patients without NODAT were included in the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between years 2007-2010, 63 patients were diagnosed as NODAT in our transplantation center from the total 267 patients who underwent renal transplantation. Among these, 159 kidney transplant recipients were selected.
Key inclusion criteria (1 listed)
- Patients who underwent renal transplantation between years 2007-2010 in our transplantation clinic with routine periodical follow-up.
Key exclusion criteria (12 listed)
- irregular drug usage or patient incompliance
- lack of regular follow-up data
- pretransplant diabetes mellitus history
- bone marrow transplant or other solid organs before or at the time of transplantation (including previous kidney transplantation)
- malign disease, rheumatologic or chronic inflammatory disease of unknown origin, systemic vasculitis history
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
Left ventricular hypertrophy
Time frame: 3 years follow-up after transplantation
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 7 Nov 2013.
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.
Siren Sezer, Prof. Dr. study chair
Baskent University, Department of Nephrology
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 Diabetes Mellitus Nos New Onset and Hypertrophy, Left Ventricular, run by Baskent University at 1 site in Turkey (Türkiye).
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 1 inclusion and 12 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 7 Nov 2013. 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 Turkey (Türkiye). 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?
Left ventricular hypertrophy (time frame: 3 years follow-up after transplantation). 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 7 Nov 2013.