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Glucose Control in Pre-Diabetic Renal Transplant Patients

NCT01346254 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2011-12-05

No results posted yet for this study

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.

Conditions

  • Impaired Glucose Tolerance
  • Kidney Transplantation

Interventions

DRUG

Vildagliptin

50mg tablets once daily 20 min before breakfast for 3 months

DRUG

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.

Sponsors & Collaborators

  • Marcus Saemann

    lead OTHER

Principal Investigators

  • Marcus Säemann, MD · Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01346254 on ClinicalTrials.gov