The Association Between Oxidative Stress and Carbohydrate Metabolism Disorders in G6PD Deficient Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Changes in glutathione following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
研究概览
简要总结
The purpose of this study is to investigate the effects of alpha-lipoic acid supplementation on redox status, physiological and biochemical parameters in diabetic individuals with G6PD deficiency, after acute exercise.
详细描述
In a randomized double-blind, crossover design, a total of forty people will participate in the research voluntarily: (a) ten people with G6PD (Mediterranean type) enzyme deficiency), (b) ten people with G6PD (Mediterranean type) enzyme deficiency and a disorder of carbohydrate metabolism (diabetes, prediabetes), (c) ten people with a disorder of carbohydrate metabolism (diabetes mellitus and prediabetes) and, (d) ten people without any health problem (control group). They will be supplemented with either 600 mg of alpha-lipoic acid (experimental condition) or placebo (control condition) every day for 4 weeks, separated by a 4-week washout period. All participants will be randomly assigned to both conditions.
Before intervention, all participants will be informed about the study protocol, fill a medical history questionnaire and sign an informed consent form. Moreover, measurements of anthropometric characteristics and physiological parameters, as well as a VO2peak test will be performed.
Participants will perform a trial of exercise (70% VO2peak for 45min and 90% till exhaustion) before and after each condition (i.e. a total of 4 trials). Blood samples will be collected before, immediately after and 1 hour after each exercise trial. Moreover, measurements of anthropometric characteristics, physiological and psychological parameters will be performed before and after each condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with normal G6PD activity
- •Individuals with G6PD deficiency
- •Individuals with CHO metabolism disorders (diabetes, prediabetes)
- •Individuals with G6PD deficiency and CHO metabolism disorders (diabetes, prediabetes)
排除标准
- •Health problems that contraindicate participation to exercise
- •Should not take any medication that affects the body's antioxidant mechanisms as well as dietary supplements containing antioxidants
- •Women during lactation or gestation
结局指标
主要结局
Changes in glutathione following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
时间窗: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DTNB method.
Changes in bilirubin following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
时间窗: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Index of blood redox status. Spectrophotometric assay for the determination of bilirubin using a clinical chemistry analyzer with commercially available kits.
Changes in total antioxidant capacity following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
时间窗: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DPPH method.
Changes in protein carbonyls following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
时间窗: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DNPH method.
Changes in uric acid following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
时间窗: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using a clinical chemistry analyzer with commercially available kits.
Changes in lipid peroxidation following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
时间窗: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Index of blood redox status. Determination of lipid peroxidation using malondialdehyde production assessment.
Changes in blood lipids following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
时间窗: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Blood lipids (total cholesterol, LDL-c, HDH-c, triglycerides). Spectrophotometric assays for the determination of blood lipids using a clinical chemistry analyzer with commercially available kits.
Changes in insulin resistance following 4 weeks of supplementation and placebo.
时间窗: Before and following 4 weeks of supplementation and placebo.
Measurement of blood glucose and insulin levels to assess HOMA-IR and evaluate insulin resistance. Spectrophotometric assay for the determination of blood glucose using a clinical chemistry analyzer with commercially available kits.Determination of blood insulin using commercially available Eliza kits.
Changes in glycated hemoglobin (HbA1c) following 4 weeks of supplementation and placebo.
时间窗: Before and following 4 weeks of supplementation and placebo.
Measurement of HbA1c using commercially available kits.
次要结局
- Changes in body mass index following 4 weeks of intervention and placebo.(Before and following 4 weeks of supplementation and placebo.)
- Changes in resting heart rate following 4 weeks of intervention and placebo.(Before and following 4 weeks of supplementation and placebo.)
- Changes in body composition following 4 weeks of intervention and placebo.(Before and following 4 weeks of supplementation and placebo.)
- Changes in waist-to-hip ratio following 4 weeks of intervention and placebo.(Before and following 4 weeks of supplementation and placebo.)
- Changes in blood pressure following 4 weeks of intervention and placebo.(Before and following 4 weeks of supplementation and placebo.)
- Changes in complete blood count following 4 weeks of intervention and placebo.(Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo))
- Changes in psychometric test following 4 weeks of intervention and placebo.(Before and following 4 weeks of supplementation and placebo.)
- Trial of VO2peak estimation.(Before intervention.)
- Superoxide dismutases (SOD)(Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo))
- Nicotinamide-adenine dinucleotide phosphate (NADPH)(Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo))
- Glutathione Reductase (GR)(Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo))
- Glutathione peroxidase (GPx)(Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo))
- G6PD enzyme activity in erythrocytes(Before intervention. During GTT (blood samples at 0, 30, 60, 90 and 120 minutes after intake of 75 g glucose). Also before, immediately after and 1, 2, 24 hours after each trial of exercise, in both conditions (supplement and placebo).)
- Glucose Tolerance Test (GTT)(Before intervention (blood samples at 0, 30, 60, 90 and 120 minutes after intake of 75 g glucose).)
研究者
Athanasios Z. Jamurtas
Principal Investigator
University of Thessaly