Glucose Control in Pre-Diabetic Renal Transplant Patients

Study Overview
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Brief Summary
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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.

Official Title
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Glucose Control in Pre-Diabetic Renal Transplant Patients: Efficacy and Safety of Vildagliptin and Pioglitazone

Conditions
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Impaired Glucose Tolerance, Kidney Transplantation

Intervention / Treatment
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* Drug: Vildagliptin
* Drug: Pioglitazone
* Behavioral: Life-Style Modification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br>16 patients randomized into this arm will receive vildagliptin (Galvus) 50mg orally once daily | Drug: Vildagliptin<br>* 50mg tablets once daily 20 min before breakfast for 3 months<br>* Other names: Galvus;Behavioral: Life-Style Modification<br>* All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.<br>|
| Experimental: Pioglitazone<br>16 patients randomized into this arm will receive pioglitazone (Actos) 30mg orally once daily | Drug: Pioglitazone<br>* 30mg tablets once daily 20 min before breakfast for 3 months<br>* Other names: Actos;Behavioral: Life-Style Modification<br>* All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.<br>|
| Placebo Comparator: Placebo<br>16 patients randomized into this arm will receive placebo medication orally once daily | Behavioral: Life-Style Modification<br>* All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycated hemoglobin | HbA1c will be measured after three months and compared between the study arms | 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 | 3 months | 
| Liver function | Liver enzymes (ALAT, ASAT, Gamm-GT) will be measured at the start of the study and after three months treatment | 3 months | 
| Lipid profiles | Lipid profiles will be analyzed at the beginning and end of the study including Cholesterol, HDL, LDL and triglycerides. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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