Efficacy and Safety of Resveratol I Pediatric and Adolescence With Type 1 Diabetic Nephropathy: A Six Months Preliminary Exploratory Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in time in range at the study endpoint.
研究概览
简要总结
Background: Food-derived compounds have been shown to have beneficial effects in type 1 diabetes mellitus (T1DM). Among these compounds, resveratrol (3,5,4'-trihydroxystilbene) which is found in grapes, peanuts, cranberries. Resveratrol has a wide range of effects including antimicrobial, anti-inflammatory, anti-apoptotic, anticancer, anti-oxidative and cardio- protective effects. Resveratrol is capable of inducing beneficial effects in diabetic animals and thereby, ameliorates diabetes. Recently, resveratrol showed beneficial effects in adults with T1DM. Objectives: Therefore, we performed a randomized-controlled trial to assess the effect of oral resveratrol supplementation on glycemic control, lipid profile and kidney injury molecule-1 (KIM-1) levels in pediatric patients with T1DM and diabetic nephropathy. Methods: This study included 60 children and adolescents with T1DM. Enrolled patients aged 12-18 years with disease duration > 5 years and have diabetic nephropathy. Patients were randomly assigned into two groups; intervention group (group A) who received oral resveratrol tablets 250 mg twice daily. The other group (group B) did not receive any supplementation and served as a control group. Both groups were followed-up for 6 months with assessment of fasting blood glucose (FBG), HbA1c, urinary albumin creatinine ratio (UACR) and KIM-1 levels. Insulin sensitivity score and estimated glucose disposal rate (eGDR) were calculated.
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 (Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T1DM.
- •Patients aged 12-18 years with at least 5 years disease duration.
- •Active diabetic nephropathy in the form of microalbuminuria (urinary albumin excretion [UAE] 30-299 mg/g creatinine). The presence of persistent microalbuminuria was confirmed by finding two or all of three samples abnormal over a 3- to 6-months period prior to study despite angiotensin converting enzyme inhibitors (ACE-Is) (Tabaei et al., 2001; Molitch et al., 2004; Donaghueet al., 2018).
- •Hemoglobin A1c (HbA1c) ≤9.0%.
- •Patients on regular visit to clinic.
- •Patients on regular insulin therapy.
排除标准
- •Patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes (aminotransferases levels higher than twice the upper normal limit).
- •Patients with renal impairment due to cause other than diabetes.
- •Patients with hypertension.
- •Hyper- or hypo-thyroidism.
- •Hepatitis virus infection (B or C) or any evidence of infection.
- •Hypoglycaemic unawareness or recurrent severe hypoglycaemic episode in 6 months prior to recruitment.
- •Recurrent diabetic ketoacidosis (more than 2 episodes in the previous 12 months).
- •Serious co-morbidities.
- •Patients were already on anti-hypertensive drugs or any antioxidant therapy such as vitamin supplements.
- •Taking any vitamins or food supplements one month before study.
- •Patients who have an allergy to grapes, berries, and peanuts.
- •Participation in a previous investigational drug study within 3 months preceding screening.
研究组 & 干预措施
Resveratol
干预措施: Resveratol (Dietary Supplement)
Control
干预措施: Placebo (Other)
结局指标
主要结局
Improvement in time in range at the study endpoint.
时间窗: 6 months.
次要结局
- Change in serum KIM-1 measured by Elisa at the study endpoint.(6 months)
研究者
Nouran yousef
Assistant Professor
Ain Shams University