A Clinical Trial to Prevent New Onset Diabetes After Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation
研究概览
简要总结
Specific Aim 1: To determine the clinical efficacy of early initiation of insulin therapy in decreasing the incidence of NODAT among de novo kidney transplant patients with manifested post-transplant hyperglycemia during the first week after transplantation.
Hypothesis 1: Early initiation of insulin therapy protects beta-cell from early stress related to the surgery and use of higher doses of immunosuppressive medications, and leads to lower incidence of NODAT at 1 and 2 years.
Specific Aim 2: To determine the improvement in overall glycemic control with the early initiation of insulin therapy.
Hypothesis 2: Early initiation of insulin therapy results in greater overall control of glycemia compared to standard care of dietary counseling, life-style modification, oral hypoglycemic agents and/or insulin as needed at 1 year.
Specific Aim 3: To determine the improvement in beta-cell function among patients assigned to the early initiation of insulin therapy at one year post-transplantation.
Hypothesis 3: Early initiation of insulin therapy protects beta-cell from glucotoxicity of post-transplant hyperglycemia and preserves better beta-cell function at 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (> 18 years) with end stage renal disease (ESRD) undergoing kidney transplantation;
- •Standard triple immunosuppressive medications following kidney transplantation including tacrolimus, mycophenolate mofetil and corticosteroids;
- •Capable to understand the study protocol and to give informed consent;
排除标准
- •Type 1 and 2 Diabetes Mellitus (DM) either as co-morbidity or cause of ESRD;
研究组 & 干预措施
Insulin treatment for hyperglycemia
Neutral Protamine Hagedorn (NPH) Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG > 240, NPH initiation: 14, dose increases by 4; For pts. with CPG > 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG > 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG > 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG <60 mg/dl, NPH initiation: 0, ½ of previous dose.
干预措施: Insulin treatment for hyperglycemia (Drug)
结局指标
主要结局
The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation
时间窗: 12 months
NODAT will be defined according to American Diabetes Association definition: 1. Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or 2. 2 hours Oral Glucose Tolerance Test (OGTT) values equal or greater than 200 mg/dl; and/or 3. Glycosylated hemoglobin A1c equal or greater than 6.5; and/or 4. On oral hypoglycemic agents and/or insulin therapy; Incidence is measured in terms of number of participants who meet any of these 4 criteria.
次要结局
- The Incidence of New Onset of Diabetes After Transplant (NODAT) 24 Months After Kidney Transplantation(24 months)
研究者
Akinlolu Ojo
Emeritus Professor of Medicine, Active
University of Michigan