Glucose Control in Pre-Diabetic Renal Transplant Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Impaired Glucose Tolerance Kidney Transplantation	Drug: Vildagliptin Drug: Pioglitazone Behavioral: Life-Style Modification	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Glucose Control in Pre-Diabetic Renal Transplant Patients: Efficacy and Safety of Vildagliptin and Pioglitazone

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation Pre-diabetes

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Oral glucose tolerance test (OGTT) [ Time Frame: three months ] [ Designated as safety issue: No ]
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 Outcome Measures:

glycated hemoglobin [ Time Frame: 3 months ] [ Designated as safety issue: No ]
HbA1c will be measured after three months and compared between the study arms
Renal function [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Liver enzymes (ALAT, ASAT, Gamm-GT) will be measured at the start of the study and after three months treatment
Lipid profiles [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Lipid profiles will be analyzed at the beginning and end of the study including Cholesterol, HDL, LDL and triglycerides.

Enrollment:	51
Study Start Date:	December 2009
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vildagliptin 16 patients randomized into this arm will receive vildagliptin (Galvus) 50mg orally once daily	Drug: Vildagliptin 50mg tablets once daily 20 min before breakfast for 3 months Other Name: Galvus Behavioral: Life-Style Modification All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.
Experimental: Pioglitazone 16 patients randomized into this arm will receive pioglitazone (Actos) 30mg orally once daily	Drug: Pioglitazone 30mg tablets once daily 20 min before breakfast for 3 months Other Name: Actos Behavioral: Life-Style Modification All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.
Placebo Comparator: Placebo 16 patients randomized into this arm will receive placebo medication orally once daily	Behavioral: Life-Style Modification All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.

Eligibility

Ages Eligible for Study:	18 Years to 81 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346254

Locations

Austria
Allgemeines Krankenhaus der Stadt Wien, Universitätskliniken
Wien, Austria, 1090

Sponsors and Collaborators

Marcus Saemann

Investigators

Principal Investigator:

Marcus Säemann, MD

Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis

More Information

No publications provided

Responsible Party:	Marcus Saemann, Dr, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT01346254 History of Changes
Other Study ID Numbers:	GCPD
Study First Received:	April 29, 2011
Last Updated:	December 2, 2011
Health Authority:	Austria: Federal Institute for Drugs and Medicinal Devices (AGES PharmMed)

Keywords provided by Medical University of Vienna:

after

Additional relevant MeSH terms:

Glucose Intolerance
Prediabetic State
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Pioglitazone

Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013

Glucose Control in Pre-Diabetic Renal Transplant Patients (GCPD)