Glucose Control in Pre-Diabetic Renal Transplant Patients: Efficacy and Safety of Vildagliptin and Pioglitazone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Oral glucose tolerance test (OGTT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Vildagliptin
16 patients randomized into this arm will receive vildagliptin (Galvus) 50mg orally once daily
干预措施: Vildagliptin (Drug)
Vildagliptin
16 patients randomized into this arm will receive vildagliptin (Galvus) 50mg orally once daily
干预措施: Life-Style Modification (Behavioral)
Pioglitazone
16 patients randomized into this arm will receive pioglitazone (Actos) 30mg orally once daily
干预措施: Pioglitazone (Drug)
Pioglitazone
16 patients randomized into this arm will receive pioglitazone (Actos) 30mg orally once daily
干预措施: Life-Style Modification (Behavioral)
Placebo
16 patients randomized into this arm will receive placebo medication orally once daily
干预措施: Life-Style Modification (Behavioral)
结局指标
主要结局
Oral glucose tolerance test (OGTT)
时间窗: 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.
次要结局
- glycated hemoglobin(3 months)
- Renal function(3 months)
- Liver function(3 months)
- Lipid profiles(3 months)
研究者
Marcus Saemann
Dr
Medical University of Vienna