A Phase 2 interventional study of Vildagliptin and Pioglitazone in Impaired Glucose Tolerance and Kidney Transplantation, sponsored by Marcus Saemann. Completed at 1 site in Austria. Open to participants aged 18 Years to 81 Years. Per ClinicalTrials.gov, last updated 2011-12-05.
Sponsored by Marcus Saemann · Phase 2, Interventional, and Treatment
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.
792 studies on the registry are indexed under Glucose Intolerance; 126 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 656 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →Marcus Saemann is the lead sponsor of 4 studies on the registry; none are open to participants now.
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16 patients randomized into this arm will receive vildagliptin (Galvus) 50mg orally once daily
Drug: Vildagliptin · Behavioral: Life-Style Modification
16 patients randomized into this arm will receive pioglitazone (Actos) 30mg orally once daily
Drug: Pioglitazone · Behavioral: Life-Style Modification
16 patients randomized into this arm will receive placebo medication orally once daily
Behavioral: Life-Style Modification
50mg tablets once daily 20 min before breakfast for 3 months
Also known as: Galvus
30mg tablets once daily 20 min before breakfast for 3 months
Also known as: Actos
All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.
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.
Time frame: three months
glycated hemoglobin
HbA1c will be measured after three months and compared between the study arms
Time frame: 3 months
Renal function
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
Time frame: 3 months
Liver function
Liver enzymes (ALAT, ASAT, Gamm-GT) will be measured at the start of the study and after three months treatment
Time frame: 3 months
Lipid profiles
Lipid profiles will be analyzed at the beginning and end of the study including Cholesterol, HDL, LDL and triglycerides.
Time frame: 3 months
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Vildagliptin · Pioglitazone
Marcus Saemann