A Single Center, Randomized, Double-blind Controlled Trial of Sitagliptin Versus Placebo to Reduce the Incidence and Severity of New-onset Diabetes After Kidney Transplant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- 2-hour Oral Glucose Tolerance Test-derived Blood Sugar
研究概览
简要总结
The purpose of this study is to determine whether sitagliptin is effective in preventing the development of new-onset diabetes after kidney transplant (NODAT). Up to one-third of previously non-diabetic patients develop NODAT after a kidney transplant. Corticosteroids and calcineurin inhibitors are two commonly utilized anti-rejection medications that contribute to diabetes development through multiple mechanisms; including decreased insulin production by the pancreas. Sitagliptin is an oral medication that results in increased insulin secretion. We hypothesize that administration of sitagliptin to transplant recipients identified to be at risk for diabetes development will reduce the incidence and severity of NODAT.
详细描述
This will be a single-center, randomized, double-blind trial to evaluate the efficacy of sitagliptin to prevent the development of new-onset diabetes after transplant (NODAT) in previously non-diabetic patients with post-operative hyperglycemia following living-donor or deceased-donor kidney transplant. In this trial, previously non-diabetic adult patients with hyperglycemia (random blood sugar >200mg/dL) in the first 72 hours following kidney transplant will be screened to determine eligibility based on inclusion/exclusion criteria. Patients that meet study entry criteria will be stratified based on HbA1c (<5.7 or 5.7-6.4%) and randomized in a 1:1 ratio to one of two treatment groups: sitagliptin versus placebo. Fifty patients (25 per group) will be enrolled. Dosing period will be 3 months at which time study drug will be discontinued and patients will be followed for an additional 3 month period.
Study visits will occur at 0, 1, 3 and 6 months. A HbA1c and 2-hour oral glucose tolerance test (OGTT) will be obtained at the 3 and 6 month study visit.
Screening period (Visit 1)
All patients presenting for living-donor or deceased donor kidney transplant will have a medical history, medication history, vital signs, height, weight, body mass index, physical exam, random blood sugar (BS), HbA1c and EKG done as part of routine pre-transplant protocol at Barnes Jewish Hospital. Patients with hyperglycemia, defined as a random blood sugar ≥ 200 mg/dL, in the first 72 hours after kidney transplant will be screened to determine eligibility for the study based on inclusion and exclusion criteria.
Randomization (Visit 2)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 (≥18 yo) recipient of living-donor or deceased donor kidney transplant
- •Blood sugar ≥ 200 mg/dL in first 72 hours after transplant
- •No history of diabetes or prior treatment with insulin or oral hypoglycemic agents
排除标准
- •A1c of ≥6.5% measured immediately pre-transplant
- •Recipient of simultaneous kidney-pancreas, kidney-liver, kidney-heart, or kidney-lung transplant
- •Prior non-renal solid organ transplant
研究组 & 干预措施
Sitagliptin
Sitaglipitin tablets will be administered orally for 3 months from randomization
Initial dose will be 100mg/daily, adjusted per renal function:
Creatinine clearance > or = 50mL/min: 100mg/day Creatinine clearance > or = 30 and <50mL/min: 50mg/day Creatinine clearance <30 mL/min or on dialysis: 25mg/day
干预措施: Sitagliptin (Drug)
Placebo
Placebo tablets (identical to active comparator in appearance) will be administered orally for 3 months. Starting dose and adjustment based on renal function will be identical to active comparator
干预措施: Placebo (Drug)
结局指标
主要结局
2-hour Oral Glucose Tolerance Test-derived Blood Sugar
时间窗: 3 months
Change in 2-hour OGTT-derived blood sugar will be measured at three months and again at six months. These are 3 month OGTT results
次要结局
- Normal 2-hour Oral Glucose Tolerance Test-derived Blood Sugar(3 months)
- 6 Month OGTT Result (Completion of Washout From Study Drug)(6 months)