Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Glucose metabolism disorders during tacrolimus treatment
研究概览
简要总结
Many people who receive a kidney transplant develop problems with how their body processes sugar (glucose). This includes conditions like prediabetes and diabetes, which can lead to more health issues, such as heart problems and infections.
One of the main medications used after a kidney transplant, called tacrolimus, can contribute to these sugar problems. Tacrolimus helps protect the new kidney, but it can also harm the cells in the pancreas that produce insulin, a hormone that controls blood sugar. Other factors, such as stress on the body and insulin resistance, can make things worse.
The effect of tacrolimus on blood sugar may depend on how the body processes the drug. Some people break down tacrolimus quickly (fast metabolizers), so they need higher doses to reach the right level in their blood. Others break it down more slowly (slow metabolizers) and require lower doses. Doctors can measure how fast someone metabolizes tacrolimus using aparameter called the concentration-to-dose (C/D) ratio.
This study aims to find out what increases the risk of developing blood sugar problems after a kidney transplant. It will focus on how quickly patients process tacrolimus and whether this affects their risk of developing diabetes. The study will also look at how common these issues are in kidney transplant patients in Poland.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Recipients of a kidney transplant from a living or deceased donor
- •Standard immunosuppressive regimen post-kidney transplantation (KTx) including Envarsus®
- •LCP Tacrolimus therapy initiated from the day of KTx or conversion from another tacrolimus formulation to LCP Tacrolimus by day 8 at the latest, according to the institution's routine practice
- •Informed patient consent to participate in the study
排除标准
- •Diagnosis of diabetes (type 1 or type 2) treated with diet or glucose-lowering drugs
- •Random glycemia/HbA1c levels justifying a diagnosis of diabetes at the time of study enrollment
- •Kidney retransplantation
- •Recipients of a multi-organ transplant
- •Use of glucagon-like peptide-1 (GLP-1) receptor agonists for weight loss
- •Use of flozins for renal or cardiac indications
- •Chronic use of drugs affecting carbohydrate metabolism, such as glucocorticosteroids
结局指标
主要结局
Glucose metabolism disorders during tacrolimus treatment
时间窗: The endpoint will be determined at 3, 6, and 12 months after transplantation
Percentage of patients diagnosed with: * Impaired fasting glucose and/or glucose intolerance (prediabetes) * Post-transplant diabetes mellitus (PTDM) requiring pharmacotherapy,
Risk factors for glucose metabolism disorders
时间窗: 3, 6, and 12 months after transplantation
Odds ratio for glucose metabolism disorders (prediabetes, PTDM) for the following variables: the rate of tacrolimus metabolism, cumulative tacrolimus exposure, cumulative glicocorticosteroid exposure, age, sex, body mass index
次要结局
- Fasting glucose(over a period of 1-12 months)