Safety and Efficacy of Resveratrol for the Treatment of Non-Alcoholic Fatty Liver Disease and Associated Insulin Resistance in Overweight and Obese Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Efficacy Outcome
研究概览
简要总结
The current project is designed as a 30-day pilot trial to demonstrate the safety and tolerability of resveratrol therapy in overweight adolescents to decrease liver fat, and improve insulin sensitivity to prevent type 2 diabetes.
详细描述
Pilot study of 10 overweight or obese children with MRS determined fatty liver randomized to resveratrol or placebo. Primary outcome measures include change in liver triglyceride content as determined by MRS and improvement in insulin resistance as determined by the area under the curve of glucose excursion during a 75 gram oral glucose tolerance test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13 to <18 years of age
- •BMI considered overweight (BMI > 25 kg/m2 ) or obese (BMI > 30 kg/m2 )
- •Confirmed 1H-MRS defined hepatic steatosis (>5.5% fat/water)
- •Parent/Guardian willing and able to provide written, signed informed consent, and subjects willing to co-sign parental consent
- •Sexually active subjects must be willing to use an acceptable method of contraception
- •Females of child bearing potential must have a negative pregnancy test at screening.
排除标准
- •The use of any chronic medications with the exception of oral birth control and natural health products with the exception of multivitamins.
- •Adolescents with altered insulin sensitivity or tissue lipid content unrelated to obesity and the metabolic syndrome, including:
- •type 2 diabetes; present or previous malignancy renal disease, hypertension (anyone who has BPs over the 99th percentile for age and gender) or liver disease;
- •significant weight loss (10% in last six months) or enrolled in weight loss program in the six months prior to the study;
- •self-reported history of alcohol consumption of greater than two drinks per day and/or drinking alcohol more than once weekly;
- •report using non-prescription recreational drugs;
- •allergies or sensitivities to any of the ingredients in the investigational product or placebo;
- •females breastfeeding at screening or planning on becoming pregnant at any time during the study;
结局指标
主要结局
Efficacy Outcome
时间窗: Week 4
To determine efficacy of resveratrol to reduce hepatic and cardiac triglyceride content in adolescents with NAFL MR spectroscopy will be performed using a 3.0-Tesla whole-body magnet. Sixty-four spectra will be acquired and averaged for the determination of intracellular water and lipid content. LCModel software will be used to isolate and quantify lipid and water peaks. Hepatic steatosis will be defined as hepatic triglyceride content of \>.5% fat/water.
Safety/ Adverse Event Outcome
时间窗: Week 8
1. Primary Side effect profile determined by participant interview. Side effect profile determined by serum biochemistry: AST, ALT, total and conjugated bilirubin, Creatinine, sodium, potassium, calcium, magnesium, chloride and TC02, haemoglobin, haematocrit, white blood cell and platelet counts, erythrocytes, and fasting lipid levels (total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides). Fasting glucose and insulin levels. PT/INR and PTT levels. 2. Vital signs
次要结局
- Efficacy Outcome(Week 4)
研究者
Dr. Brandy Wicklow
Principal Investigator MD
University of Manitoba