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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin | Experimental | 16 patients randomized into this arm will receive vildagliptin (Galvus) 50mg orally once daily |
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| Pioglitazone | Experimental | 16 patients randomized into this arm will receive pioglitazone (Actos) 30mg orally once daily |
|
| Placebo | Placebo Comparator | 16 patients randomized into this arm will receive placebo medication orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | 50mg tablets once daily 20 min before breakfast for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| glycated hemoglobin | HbA1c will be measured after three months and compared between the study arms | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Säemann, MD | Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus der Stadt Wien, Universitätskliniken | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32803882 | Derived | 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. |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Pioglitazone | Drug | 30mg tablets once daily 20 min before breakfast for 3 months |
|
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| Life-Style Modification | Behavioral | All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet. |
|
| 3 months |
| Liver function | Liver enzymes (ALAT, ASAT, Gamm-GT) will be measured at the start of the study and after three months treatment | 3 months |
| Lipid profiles | Lipid profiles will be analyzed at the beginning and end of the study including Cholesterol, HDL, LDL and triglycerides. | 3 months |
| D006571 |
| Heterocyclic Compounds |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |