Effect of Hydroxychloroquine on Diabetic Nephropathy – a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Change in proteinuria
研究概览
简要总结
Early identification and management of diabetes-related complications could help in preventing progression to End stage renal disease. Better management strategies lead to delaying the development of diabetic complications.
All patients with type 2 diabetes presenting to the Department of General Medicine or Nephrology will be evaluated for inclusion in the study. The subjects will be followed up for a period of 6 months. It is a Single-center, randomized, double blind, placebo-controlled trial, with a total of 60 participants (30 experimental arm, 30 placebo arm). The study will have a 4 week run-in period during which telmisartan dose will be maximised, followed by drug initiation with a 6 month follow up. Participants will receive placebo or hydroxychloroquine twice a day. Hydroxychloroquine will be given at a dose of 200mg twice a day if subjects weight is more than 40kg, or 100mg od if less than 40kg.
At baseline, demographic characteristics such as Age, Gender, duration of Diabetes Mellitus, history of Hypertension, Cardiac disease, and CKD will be obtained. The subject’s blood pressure, Hemoglobin, Random blood sugar, Creatinine, urine albumin to creatinine ratio (UACR) will be evaluated at randomisation. The following investigations will be done at the end of run-in period, and at end of 6 months: Hemoglobin, Fasting Blood Sugar, Serum Creatinine, highly sensitive C-reactive peptide, fasting serum Insulin, UACR, HbA1c and lipid profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Presence of Diabetic Nephropathy.
排除标准
- •Pregnant Women
- •People not consenting for study
- •Participation in any other clinical trial
- •History of intolerance to study drug
- •Patients with history of cardiac arrhythmias or prolonged QT interval
- •Patients with severe retinopathy
- •Patients requiring in-patient admission at time of enrolment
- •Any other condition which in the opinion of the investigator, would put the safety of the participant at risk, impede compliance or hinder completion of the study.
结局指标
主要结局
1. Change in proteinuria
时间窗: 12 weeks, 24 weeks
2. Change in estimated glomerular filtration rate
时间窗: 12 weeks, 24 weeks
次要结局
- 1. Effect of hydroxychloroquine on glycemic control(2. Effect of hydroxychloroquine on lipid profile)