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Completed

NCT Number: NCT01346254

Glucose Control in Pre-Diabetic Renal Transplant Patients

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.

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Key information

Conditions

Impaired Glucose Tolerance Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Kidney Transplantation Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allgemeines Krankenhaus der Stadt Wien, Universitätskliniken

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vildagliptin

Drug

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

Other names: Galvus

pioglitazone

Drug

30mg tablets once daily 20 min before breakfast for 3 months

Other names: Actos

Life-Style Modification

Behavioral

All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.

Primary outcomes

  1. Oral glucose tolerance test (OGTT)

    Time frame: 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 outcomes

  1. glycated hemoglobin

    Time frame: 3 months

    HbA1c will be measured after three months and compared between the study arms

  2. Renal function

    Time frame: 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

  3. Liver function

    Time frame: 3 months

    Liver enzymes (ALAT, ASAT, Gamm-GT) will be measured at the start of the study and after three months treatment

  4. Lipid profiles

    Time frame: 3 months

    Lipid profiles will be analyzed at the beginning and end of the study including Cholesterol, HDL, LDL and triglycerides.

Sponsors and collaborators

Lead sponsor

Marcus Saemann

Other

Registry information

Official study title

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

Acronym: GCPD

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 2, 2011
Registry last updated
Dec 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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