2023-506437-29-00招募中3 期
GLP-1 receptor agonists as preventive treatment of diabetes after renal transplantation: randomized clinical trial. Study 1: Immediate Kidney Transplant Recipients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Proportion of patients with prediabetes and diabetes at 3 months after transplant, defined as one of the following criteria of the American Diabetes Association: - patients have a fasting glucose ≥126 mg/dL (7.0 mmol/L), - patients with an abnormal oral glucose tolerance test (OGTT) (value 2-h plasma glucose ≥200 mg/dL (11.1 mmol/L). The test will be carried out according to as described by the WHO, using a glucose load containing the equivalent of 75 g of anhydrous glucose dissolved in water,
研究概览
简要总结
To evaluate whether treatment with GLP-1 RA in a high-risk population in the immediate post-kidney transplant period prevents new-onset diabetes after transplantation at 3 months.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •De novo kidney transplant recipients older than 18 years,
- •No history of diabetes (by clinical history, verbal information from patients directly or with pre-transplant HbA1c ≤ 6.5%),
- •Who receive tacrolimus and prednisone as maintenance immunosuppressive treatment in the post-transplant period
- •And with high risk of PTDM defined by two of these factors: -age > 50 years; -BMI ≥ 30 kg/m2; -first degree family history of diabetes; -hypertriglyceridemia (triglyceride level >2.82 mmol/L); -prediabetes (defined by any of: fasting glucose 100–126 mg/dL (5.6–6.9 mmol/L), or HbA1c 5.7–6.4%, or if available oral glucose tolerance test prior to inclusion with values of initial glucose <126 mg/dL (7 mmol/L) and 2h after the load between 140–200 mg/dL (7.8–11 mmol/L).
- •Women of childbearing potential using effective contraception during study participation.
排除标准
- •Under 18 years of age,
- •previously diagnosed diabetes,
- •Hepatic failure
- •history of pancreatitis (acute or chronic),
- •multiple endocrine neoplasia syndrome type 2 (MEN 2),
- •personal or family history history of medullary thyroid carcinoma (MTC)
- •pregnant or lactating women
- •moderate to severe pre-existing gastroparesis
结局指标
主要结局
Proportion of patients with prediabetes and diabetes at 3 months after transplant, defined as one of the following criteria of the American Diabetes Association: - patients have a fasting glucose ≥126 mg/dL (7.0 mmol/L), - patients with an abnormal oral glucose tolerance test (OGTT) (value 2-h plasma glucose ≥200 mg/dL (11.1 mmol/L). The test will be carried out according to as described by the WHO, using a glucose load containing the equivalent of 75 g of anhydrous glucose dissolved in water,
Proportion of patients with prediabetes and diabetes at 3 months after transplant, defined as one of the following criteria of the American Diabetes Association: - patients have a fasting glucose ≥126 mg/dL (7.0 mmol/L), - patients with an abnormal oral glucose tolerance test (OGTT) (value 2-h plasma glucose ≥200 mg/dL (11.1 mmol/L). The test will be carried out according to as described by the WHO, using a glucose load containing the equivalent of 75 g of anhydrous glucose dissolved in water,
次要结局
- Number and type of additional drugs aimed at diabetes control and metabolic control (HbA1c) and hypoglycemic episodes (defined as ≤ 70 mg/dl) at 3 and 12 months after RT.
- Insulin sensitivity as measured by homeostatic model assessment calculated for insulin resistance score (HOMA-IR): HOMA-IR = [glucose (nmol/L) * insulin (μU/mL)/22.5], using fasting values and HOMA-measured β-cell function of the β-cell function index (HOMA-B) calculated as the product of 20 and basal insulin levels divided by the value of the basal glucose concentrations minus 3.5 at 3, 6, and 12 months.
- Weight change measured in kilograms (Kg) and BMI variations from pre-transplant to 3 and 12 months of follow-up; waist circumference and waist-hip circumference ratio measured per cm from pre-transplant to 3 and 12-month follow-up
- Renal function assessed by routine blood tests: serum creatinine (sCr), estimated glomerular filtration rate (eGFR) (measured by CKD-EPI formulas) and proteinuria measured by spot urine albumin/creatinine ratio (at 3 and 12 months)
- Lipid profile by routine blood tests: LDL (low-density lipoprotein) cholesterol, HDL (high-density lipoprotein) cholesterol, and triglycerides from pre-transplant to 3 and 12-month follow-up
- Incidence of death and death-censored graft loss
- Renal biopsy lesions at 12 months: volume fractions of mesangium and mesangial matrix, mesangial expansion (%)
- Analysis of the differences in the levels of immunosuppression (tacrolimus) in the GLP-1RA group. We will perform the level analysis using the pre-dose concentration of TAC at first steady state (5-7 days after onset), 15 days, 1 and 3 months. We will compare the concentration in blood of the dose standardized CT. Different genotype states of CYP3A4*22 and CYP3A5*3, and P-glycoprotein (3435CT, ABCB1) will be considered in the analysis.
- Rate of treatment interruptions as well as acute rejection episodes (Biopsy-proven Acute Rejection and Treated Acute Rejection), infection and cardiovascular events
- Proportion of patients with prediabetes and diabetes at 12 months after transplant.
研究者
Nuria Montero
Scientific
Bellvitge University Hospital
研究点 (1)
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