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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcus Saemann, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01346254
First received: April 29, 2011
Last updated: December 2, 2011
Last verified: December 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperglycemia
Metabolic Diseases
Pioglitazone
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014