Glucose Control in Pre-Diabetic Renal Transplant Patients

Marcus Saemann51 enrolled

Overview

Development of New-Onset Diabetes after Transplantation (NODAT) is common and serious complication after kidney transplantation. Patients who develop NODAT are at increased risk for loss of the transplanted organ and for diseases of the cardiovascular system. It is believed that in many patients the development of overt NODAT is preceded by a phase of impaired glucose tolerance that is called pre-diabetes. This study aims at improving glucose metabolism in patients after kidney transplantation who are in a pre-diabetic metabolic state. Patients who exhibit impaired glucose tolerance (IGT) after kidney transplantation are randomized to either receive vildagliptin (Galvus), pioglitazone(Actos) or placebo for three months. The investigators hypothesize that treatment with vildagliptin or pioglitazone leads to improved glycemic control compared to placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Impaired Glucose Tolerance Kidney Transplantation

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 81 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Time since renal transplantation \> 6 months * Stable graft function * Routine OGTT has been performed, and pre-diabetes has been diagnosed by pathological OGTT (2h, 75 g glucose, glucose level between 140 and 200 mg/dl) * Informed consent of the patient Exclusion Criteria: * Patients with type 1 or type 2 diabetes * Patients with NODAT (2h glucose level at OGTT \>200 mg/dl) * allergy against vildagliptin or pioglitazone * pregnancy * GFR\<15ml/min/1.73 with need for dialysis * hepatic impairment

Outcomes

Primary Outcomes

Oral glucose tolerance test (OGTT)

Glucose tolerance and insulin resistance three months after study start will be measured by means of a frequent sampling OGTT (75g glucose, determination of glucose, insulin and C-peptide) over 120 mins.

Time frame: three months

Secondary Outcomes

glycated hemoglobin

HbA1c will be measured after three months and compared between the study arms

Time frame: 3 months

Renal function

Renal function will be assessed by measuring serum creatinin and glomerular filtration rate (GFR)at the beginning of the study and after three months of treatment

Time frame: 3 months

Liver function

Liver enzymes (ALAT, ASAT, Gamm-GT) will be measured at the start of the study and after three months treatment

Time frame: 3 months

Lipid profiles

Lipid profiles will be analyzed at the beginning and end of the study including Cholesterol, HDL, LDL and triglycerides.

Time frame: 3 months

Glucose Control in Pre-Diabetic Renal Transplant Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes