NCT01346254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

December 5, 2011

Status Verified

December 1, 2011

Enrollment Period

1.9 years

First QC Date

April 29, 2011

Last Update Submit

December 2, 2011

Conditions

Impaired Glucose ToleranceKidney Transplantation

Keywords

after

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • glycated hemoglobin

    3 months

  • Renal function

    3 months

  • Liver function

    3 months

  • Lipid profiles

    3 months

Study Arms (3)

Vildagliptin

EXPERIMENTAL

16 patients randomized into this arm will receive vildagliptin (Galvus) 50mg orally once daily

Drug: VildagliptinBehavioral: Life-Style Modification

Pioglitazone

EXPERIMENTAL

16 patients randomized into this arm will receive pioglitazone (Actos) 30mg orally once daily

Drug: PioglitazoneBehavioral: Life-Style Modification

Placebo

PLACEBO COMPARATOR

16 patients randomized into this arm will receive placebo medication orally once daily

Behavioral: Life-Style Modification

Interventions

VildagliptinDRUG

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

Also known as: Galvus
Vildagliptin
PioglitazoneDRUG

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

Also known as: Actos
Pioglitazone
Life-Style ModificationBEHAVIORAL

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

PioglitazonePlaceboVildagliptin

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allgemeines Krankenhaus der Stadt Wien, Universitätskliniken

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 32803882DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

VildagliptinPioglitazone

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolidinedionesThiazolesSulfur CompoundsAzoles

Study Officials

  • Marcus Säemann, MD

    Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 29, 2011

First Posted

May 2, 2011

Study Start

December 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

December 5, 2011

Record last verified: 2011-12

Locations

AU(1)