The Effects of Glycine on Atherosclerosis and Metabolic Syndrome-related Parameters: A Clinical and Ex-vivo Study.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 主要终点
- LDL Cholesterol levels
研究概览
简要总结
The current study will test the central hypothesis that Glycine supplementation in humans improves Lipid profile and therefore reduces the risk of Atherosclerosis. Secondary outcomes including Insulin sensitivity and parameters related to Metabolic Syndrome (MetS) will also be measured. Furthermore, a mechanistic study in an ex-vivo model will test the hypothesis that Glycine via its key biosynthetic pathway involving Serine Hydroxymethyltransferase 2 (SHMT2), is athero-protective by inhibiting Sterol regulatory element-binding protein 2 (SREBP2)-mediated cholesterol biosynthesis in murine macrophage-like cell line.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male between the ages of 40-65 years old.
- •Fulfill at least three of the five diagnostic criteria for the Metabolic Syndrome.
- •To be able to give their written consent to participate in this study.
排除标准
- •Abnormal Liver function tests ≥ 3 times upper limit of normal (ULN).
- •Chronic liver disease other than NAFLD.
- •Previous gastric or small bowel surgery.
- •Abnormal Thyroid-stimulating hormone (TSH) level.
- •Known Tobacco Smoking more than 10 cigarettes per day.
- •Known alcohol consumption more than 2 drink per day.
- •Use of medications that include: Insulin or Insulin secretagogues, Thiazolidinediones, Glucocorticosteroids, Hormone replacement therapy.
- •Fever > 38.2 °C in the past 2 weeks.
- •Autoimmune or Auto-inflammatory disease.
- •Chronic kidney disease ≥ stage III.
- •Nephrotic syndrome.
- •Hemoglobin <12 g/dL.
- •Metal clips or implants that preclude magnetic resonance imaging.
研究组 & 干预措施
Glycine
Glycine total daily dose of 150mg/kg divided three times daily with meals (powder dissolved in 1 cup of water) for 12 weeks.
干预措施: Glycine (Dietary Supplement)
结局指标
主要结局
LDL Cholesterol levels
时间窗: 12 weeks
Change in LDL Cholesterol levels
次要结局
- HDL Cholesterol levels(12 weeks)
- HbA1C levels(12 weeks)
- Triglyceride levels(12 weeks)
研究者
Prof. Tony hayek MD
Director, Department of Internal Medicine "E".
Rambam Health Care Campus