Assessment of Renometabolic Effects of Tirzepatide in Obese Type 2 Diabetes Mellitus Patients with Shrunken Pore Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean change in eGFRcys:eGFRcr ratio,
研究概览
简要总结
This study is a 12-week, prospective, observational pilot evaluating how tirzepatide a medication for type 2 diabetes affects kidney filtration and metabolic health in obese adults with and without shrunken pore syndrome. Sixty participants (30 with shrunken pore syndrome and 30 controls) will receive standard tirzepatide dosing and undergo assessments at baseline, weeks 4, 8, and 12. Primary outcomes include the mean change in the ratio of cystatin C–based to creatinine-based estimated glomerular filtration rate and the mean change in body weight from baseline to week 12. Secondary outcomes assess glycemic control (HbA1c), adverse drug reactions, and patient-reported quality of life using validated questionnaires. Detailed clinical, laboratory, and safety evaluations at each visit will inform the impact of tirzepatide on renal-metabolic parameters in this high risk population.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Ability to provide written informed consent, BMI greater than or equal to 25 kg per m²,Diagnosed T2DM (HbA1c greter than 7 percentage), eGFRcr between 30 and 90 ml per min per 1.73 m² body surface area, Planned initiation of tirzepatide therapy based on clinical decision.
排除标准
- •Type 1 diabetes mellitus, Pregnancy or lactation, Severe GI disorders or malabsorption, Acute Kidney Injury, Severe hepatic impairment, Current diagnosis of any malignancy, Subject who participated in any other clinical investigation using an experimental drug in the past 3 months, Concurrent participation in another clinical trial.
结局指标
主要结局
Mean change in eGFRcys:eGFRcr ratio,
时间窗: Outcomes will be assessed at baseline (before starting Tirzepatide), 4 weeks, 8 weeks , and 12 weeks after starting treatment.
Mean change in body weight
时间窗: Outcomes will be assessed at baseline (before starting Tirzepatide), 4 weeks, 8 weeks , and 12 weeks after starting treatment.
次要结局
- Incidence of adverse events, especially gastrointestinal (GI) side effects,
研究者
DR M G Rajanandh
SRM College of Pharmacy, SRM IST