Evaluating the Outcome of Silymarin as an Adjunct Therapy to Renin-Angiotensin System Inhibitors in Proteinuric Type 2 Diabetic Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in HbA1c levels from baseline
研究概览
简要总结
Given the inadequacies of existing pharmacological interventions for diabetic nephropathy, this study is predicated on the hypothesis that silymarin, having shown promise in mitigating hyperglycemia in diabetic patients without nephropathy and displaying renal protective effects in animal models, merits a thorough and systematic investigation. The current body of research on silymarin, particularly human trials, is limited by small cohorts and the preliminary nature of its outcomes. This research aims to evaluate the efficacy of silymarin as an adjunctive treatment in patients with Type 2 diabetes mellitus (T2DM) already on renin-angiotensin system inhibitors, focusing on its potential to reduce proteinuria and improve renal function. The ultimate objective is to amass more definitive evidence that could potentially inform a new therapeutic approach in the management of diabetic nephropathy.
详细描述
After securing the approval from the Ethical Review Board of hospital, this study was conducted in the Nephrology Department, Lahore General Hospital, Lahore. All patients diagnosed with Type 2 Diabetes Mellitus was assessed based on the previously defined inclusion and exclusion criteria. Informed consent was obtained from all eligible participants who agreed to participate in the study.
Baseline Data Collection: Upon enrollment, demographic and clinical information including age, gender, duration of diabetes, baseline renal function tests, current medication use, and baseline measures of HBA1c, FBS, RBS and proteinuria were collected. This information was provided a comprehensive profile of each participant at the start of the study.
Treatment Allocation: Patients was randomly assigned into two groups using a lottery method:
- Group A: received 140 mg of silymarin administered orally three times daily, alongside their standard treatment with renin-angiotensin system inhibitors.
- Group B: received placebo capsule three times a day alongside their standard treatment with renin-angiotensin system inhibitors.
Monitoring and Follow-up Assessments: Participants was assessed for outcomes after at one month and 3 months to monitor changes in proteinuria and renal function. Specific tests were included:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 35-70 years.
- •Both male and female with Type II diabetes.
- •Overt proteinuria defined by urinary albumin excretion > 300 mg/24 hr. in 2 consecutive determinations despite treatment with highest FDA recommended doses of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker for at least 6 months.
- •Treatment of hyperglycemia with (but not limited to) an oral hypoglycemic agent or insulin (If a SGLT2 inhibitors is used, stable dose for at least 3 months).
- •Treatment of hypercholesterolemia with (but not limited to) one medication from the class statins.
- •Patients using stable dose of Non-Dihydropyridine Calcium Channel Blockers for at least 6 months as antihypertensive.
- •Presence of diabetic retinopathy.
- •Signing informed consent.
排除标准
- •Type I diabetes.
- •Advanced chronic kidney disease defined by estimated GFR < 30 ml/min/1.73 m2
- •Severely uncontrolled diabetes defined by HbA1C > 10%.
- •Uncontrolled hypertension defined by SBP >140 mmHg or DBP >90 mmHg despite antihypertensive therapy.
- •Patients with organ transplant history.
- •Secondary forms of hypertension with defined etiology other than diabetes mellitus.
- •Other renal diseases.
- •Chronic Heart Failure with NYHA class III or IV.
- •Active infection.
- •Pregnancy.
- •Use of one of the following medications within 2 months prior to enrollment in the study:
- •Non-steroidal anti-inflammatory agents.
- •Antioxidants supplements including vitamin E, vitamin C, N-acetyl- cysteine (NAC), Pentoxifylline, Lipoic acid, Fish-oil extracts (omega-3 fatty acids), Soy extracts (isoflavones), Green-tea preparations, Pomegranate extracts, Grape extracts.
- •Active malignancy.
- •History of drug or alcohol dependency.
- •Psychiatric or neurological condition, preventing aware consent to the study and/or adherence to the study protocol.
研究组 & 干预措施
Group Placebo
Received placebo capsule three times a day alongside their standard treatment with renin-angiotensin system inhibitors.
干预措施: Placebo (Drug)
Group Silymarin
Received 140 mg of silymarin administered orally three times daily, alongside their standard treatment with renin-angiotensin system inhibitors.
干预措施: Silymarin (Drug)
结局指标
主要结局
Change in HbA1c levels from baseline
时间窗: Outcomes monitored after three-month.
It was measured quantitatively by comparing the HbA1c levels in percentage (%) between initial recruitment and subsequent follow-up visit after three months.
Change in estimated glomerular filtration rate (eGFR) from baseline
时间窗: Outcomes monitored at one and three-month intervals
eGFR was calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula, which incorporates serum creatinine, age, sex, and race. The outcome measure was the change in eGFR in mL/min/1.73 m² at one month and three months compared to the baseline value.
Change in the urinary albumin-creatinine ratio (UACR) from baseline
时间窗: Outcomes monitored at one and three-month intervals
It was measured quantitatively by comparing the urinary albumin-creatinine ratio (UACR) in mg/g between initial recruitment and subsequent follow-up visits at one and three months.
次要结局
未报告次要终点
研究者
Muhammad Irfan Jamil
Principal Investigator
Lahore General Hospital