Impaired Glucose Tolerance, Kidney Transplantation
Conditions
Keywords
after
Brief summary
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.
Interventions
DRUGVildagliptin
50mg tablets once daily 20 min before breakfast for 3 months
DRUGPioglitazone
30mg tablets once daily 20 min before breakfast for 3 months
BEHAVIORALLife-Style Modification
All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.
Sponsors
Marcus Saemann
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 81 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral glucose tolerance test (OGTT) | three months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| glycated hemoglobin | 3 months | HbA1c will be measured after three months and compared between the study arms |
| Renal function | 3 months | 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 |
| Liver function | 3 months | Liver enzymes (ALAT, ASAT, Gamm-GT) will be measured at the start of the study and after three months treatment |
| Lipid profiles | 3 months | Lipid profiles will be analyzed at the beginning and end of the study including Cholesterol, HDL, LDL and triglycerides. |
Countries
Austria
Outcome results
None listed