Glucose Control in Pre-Diabetic Renal Transplant Patients

Phase 2

Completed

• Conditions: Impaired Glucose Tolerance; Kidney Transplantation
• Interventions: Drug: Vildagliptin; Drug: Pioglitazone; Behavioral: Life-Style Modification

• Registration Number: NCT01346254
• Lead Sponsor: Marcus Saemann

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-02
• Last Update Posted: 2011-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vildagliptin	Life-Style Modification	16 patients randomized into this arm will receive vildagliptin (Galvus) 50mg orally once daily
Pioglitazone	Life-Style Modification	16 patients randomized into this arm will receive pioglitazone (Actos) 30mg orally once daily
Placebo	Life-Style Modification	16 patients randomized into this arm will receive placebo medication orally once daily
Vildagliptin	Vildagliptin	16 patients randomized into this arm will receive vildagliptin (Galvus) 50mg orally once daily
Pioglitazone	Pioglitazone	16 patients randomized into this arm will receive pioglitazone (Actos) 30mg orally once daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Allgemeines Krankenhaus der Stadt Wien, Universitätskliniken; 🇦🇹 Wien, Austria