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

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

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 Overview

• Status: Completed
• Conditions: Kidney Transplantation; Impaired Glucose Tolerance
• Intervention / Treatment: Drug: Vildagliptin; Behavioral: Life-Style Modification; Drug: Pioglitazone

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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	Behavioral: Life-Style Modification; All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.; Drug: Pioglitazone; 30mg tablets once daily 20 min before breakfast for 3 months; Other Names: Actos
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Marcus Saemann
• Investigators: Principal Investigator: Marcus Säemann, MD, Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis

Publications and helpful links

General Publications

• Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: April 29, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Estimate): December 5, 2011
• Last Update Submitted That Met QC Criteria: December 2, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: after
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Pioglitazone; Vildagliptin
• Other Study ID Numbers: GCPD