Glucose Control in Pre-Diabetic Renal Transplant Patients

Kidney Transplantation Clinical Trial

— GCPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346254
• Other study ID #: GCPD
• Status: Completed
• Phase: Phase 2
• First received: April 29, 2011
• Last updated: December 2, 2011
• Start date: December 2009
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Institute for Drugs and Medicinal Devices (AGES PharmMed)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 81 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance
• Kidney Transplantation
• Prediabetic State

Intervention

Drug:
• Vildagliptin
50mg tablets once daily 20 min before breakfast for 3 months
• Pioglitazone
30mg tablets once daily 20 min before breakfast for 3 months

Behavioral:
• Life-Style Modification
All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus der Stadt Wien, Universitätskliniken	Wien

Sponsors (1)

Lead Sponsor	Collaborator
Marcus Saemann

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	glycated hemoglobin	HbA1c will be measured after three months and compared between the study arms	3 months	No
Secondary	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	Yes
Secondary	Liver function	Liver enzymes (ALAT, ASAT, Gamm-GT) will be measured at the start of the study and after three months treatment	3 months	Yes
Secondary	Lipid profiles	Lipid profiles will be analyzed at the beginning and end of the study including Cholesterol, HDL, LDL and triglycerides.	3 months	No