Safety and Effectiveness of Tirzepatide(Spartina )in Chronic Kidney Failure a Single-center Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- weight loss
研究概览
简要总结
Diabetes management presents a complex clinical scenario marked by several challenges, especially in chronic kidney failure. These include navigating potential drug interactions between oral antidiabetic therapies and other agents. Furthermore, these patients may experience various adverse drug effects, such as lactic acidosis, electrolyte abnormalities such as hypomagnesemia, fluid retention, and lipid derangements, which can further augment overall morbidity. Consequently, many patients receive insulin. However, prolonged intensive insulin therapy may be linked to several adverse outcomes, including an increased risk of hypoglycemia and weight gain.
Hence, a common practice is to transition to medications commonly used other populations of patients. With their established benefits on glycemic control, cardiovascular health, renal benefits, and weight management, in conjunction with the aforementioned adverse effects associated with other oral antidiabetics agents, glucagon-like peptide-1 receptor agonists have emerged as an attractive therapeutic option for patients with kidney failure.
详细描述
Investigators will conduct a single-center clinical trial at Labafinezhad Hospital in Tehran, Iran. Initially, 15 stable chronic kidney failure patients with a glomerular filtration rate < 30 cc/min but not on dialysis, will receive tirzepatide(Spartina) therapy. Inclusion criteria consisted of age ≥18 years and a history of chronic kidney failure with preexisting diabetes or obesity with a body mass index over 27.
. Major exclusion criteria included similar drug therapy for a duration of less than 3 months and nonadherence to tirzepatide therapy. After an initial screen, investigators will enroll 15 patients who meet the inclusion criteria. The project is pending Institutional Research Ethics Committee of Shahid Beheshti University of Medical Sciences approval.
Data collection at baseline involves gathering demographic information, including age, sex, weight, height, and blood type group. Furthermore, investigators will obtain information related to past medical history, including the presence of preexisting diabetes mellitus, the onset of diabetes mellitus, and the requirement of insulin therapy. Efficacy endpoints include alterations in weight, body mass index (in kilograms divided by height in meters squared), serum triglycerides, insulin requirements, fasting plasma glucose, and estimated glomerular filtration rate, computed based on the Chronic Kidney Disease Epidemiology 2021 collaboration formula. For safety outcomes, investigators will review serum lipase, thyroid-stimulating hormone levels, and liver function tests at baseline and after tirzepatide therapy. Investigators will also report on all-cause mortality. Efficacy and safety endpoint data will be collected initially at baseline (therapy initiation) and at the end of 1 and 3d months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •age ≥18 years and history of diabetes or BMI over 27
排除标准
- •Previous usage of similar therapy for less than 3 months owing to the inability to capture all efficacy and safety endpoints within this brief timeframe and/or nonadherence to tirzepatide therapy
研究组 & 干预措施
Spartina
weekly injection of Tirzepatide (Spartina)
干预措施: Tirzepatide (Drug)
结局指标
主要结局
weight loss
时间窗: kilogram of weight loss measured by same scale one and three month after injection
次要结局
未报告次要终点
研究者
nooshin dalili
Associate Professor of Nephrology
Shahid Beheshti University of Medical Sciences