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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Turkey (Türkiye)

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 groups in NCT01976689
Study groupRoleWhat they receive
Patients with New-onset DiabetesNew-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 NODATNew-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.

  1. 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.

  1. First posted6 Nov 2013 (estimated)
  2. Study startMar 2012
  3. Primary completionMar 2013
  4. Study completionSep 2013

Resources

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)
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

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.

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