Glycine "Deficiency" and the Kinetics of Acylglycine in Morbid Obesity
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acylglycine concentration
研究概览
简要总结
This study aims to evaluate the effects of oral glycine supplementation on plasma glycine concentration, intracellular glutathione (GSH) concentration, plasma acylglycine concentration, urine acylglycine concentration, and insulin resistance in subjects with morbid obesity.
This is an open-labelled trial. 20 adults with morbid obesity will be recruited. Following screening and baseline metabolic evaluations, eligible subjects will be given oral glycine supplements for 14 ± 5 days. Upon completing glycine supplementation, subjects will return for their post-supplement metabolic assessment.
The investigators hypothesize that oral glycine supplementation in morbidly obese patients normalizes plasma glycine concentration, increases intracellular GSH concentration, increases plasma and urinary acylglycine concentration, and improves insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 21-65 years
- •BMI ≥ 32.5 kg/m2
- •Able to provide informed consent
- •Able to maintain present diet throughout the study duration
排除标准
- •Weight > 150 kg
- •Type 2 Diabetes Mellitus
- •Allergy to soy
- •Ongoing treatment with weight-loss medications (e.g. orlistat, phentermine, liraglutide)
- •Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)
- •Renal impairment (estimated creatinine clearance estimated by Cockcroft-Gault Equation < 60 ml/min)
- •Haemoglobin concentration < 10 g/L
- •Serum alanine aminotransferase or aspartate aminotransferase above 2x upper limit of normal
- •Uncontrolled hypertension (BP > 180/110 mmHg)
- •Nursing mothers
- •Uncontrolled thyroid disease
- •Surgery requiring general anaesthesia within 4-weeks before enrolment
- •Psychiatric disorders requiring medication
- •Significant alcohol intake (> 1 unit per day for women and > 2 units per day for men)
- •Cancer within the last 3-years (except squamous cell and basal cell cancer of the skin)
- •Any factors likely to limit adherence to study protocol
研究组 & 干预措施
Glycine supplementation
Glycine supplementation
干预措施: Glycine (Dietary Supplement)
结局指标
主要结局
Acylglycine concentration
时间窗: 14 days
Post-treatment changes acylglycine concentration in plasma and urine
Acylcarnitine concentration
时间窗: 14 days
Post-treatment changes acylcarnitine concentration in plasma and urine
Amino acid concentration
时间窗: 14 days
Post-treatment changes amino acid concentration in plasma and red blood cell
Glutathione concentration
时间窗: 14 days
Post-treatment changes in glutathione concentration in plasma and red blood cell
次要结局
- Insulin resistance index(14 days)