Glucose Control in Pre-Diabetic Renal Transplant Patients
NCT ID: NCT01346254
Last Updated: 2011-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2009-12-31
2011-11-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vildagliptin
16 patients randomized into this arm will receive vildagliptin (Galvus) 50mg orally once daily
Vildagliptin
50mg tablets once daily 20 min before breakfast for 3 months
Life-Style Modification
All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.
Pioglitazone
16 patients randomized into this arm will receive pioglitazone (Actos) 30mg orally once daily
Pioglitazone
30mg tablets once daily 20 min before breakfast for 3 months
Life-Style Modification
All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.
Placebo
16 patients randomized into this arm will receive placebo medication orally once daily
Life-Style Modification
All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.
Interventions
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Vildagliptin
50mg tablets once daily 20 min before breakfast for 3 months
Pioglitazone
30mg tablets once daily 20 min before breakfast for 3 months
Life-Style Modification
All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
81 Years
ALL
No
Sponsors
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Marcus Saemann
OTHER
Responsible Party
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Marcus Saemann
Dr
Principal Investigators
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Marcus Säemann, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
Locations
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Allgemeines Krankenhaus der Stadt Wien, Universitätskliniken
Vienna, , Austria
Countries
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References
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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.
Other Identifiers
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GCPD
Identifier Type: -
Identifier Source: org_study_id