New-onset Diabetes and Left Ventricular Hypertrophy in Renal Transplantation

NCT01976689 | Completed

• 1 other identifier: TIBU009158
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus Nos New Onset; Hypertrophy, Left Ventricular; Vascular Stiffness

Keywords

Glucose Regulation; Left Ventricular Hypertrophy; New-onset Diabetes; Renal Transplantation

Outcome Measures

Primary Outcomes (1)

• Left ventricular hypertrophy

  3 years follow-up after transplantation

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Patients who underwent renal transplantation between years 2007-2010 in our transplantation clinic with routine periodical follow-up.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University Medical School

Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Siren Sezer, Prof. Dr.

  Baskent University, Department of Nephrology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, Neprology Fellow

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 6, 2013
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 7, 2013

Record last verified: 2013-11

Locations

TU (1)