Oxidative Stress Clinical Trial
Official title:
The Association Between Oxidative Stress and Carbohydrate Metabolism Disorders in G6PD Deficient Individuals
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | June 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Thessaly |
Georgakouli K, Deli CK, Zalavras A, Fatouros IG, Kouretas D, Koutedakis Y, Jamurtas AZ. Alpha-lipoic acid supplementation up-regulates antioxidant capacity in adults with G6PD deficiency. Food Chem Toxicol. 2013 Nov;61:69-73. doi: 10.1016/j.fct.2013.01.055. Epub 2013 Feb 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in total antioxidant capacity following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DPPH method. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | |
Primary | Changes in glutathione following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DTNB method. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | |
Primary | Changes in uric acid following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using a clinical chemistry analyzer with commercially available kits. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | |
Primary | Changes in bilirubin following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | Index of blood redox status. Spectrophotometric assay for the determination of bilirubin using a clinical chemistry analyzer with commercially available kits. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | |
Primary | Changes in lipid peroxidation following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | Index of blood redox status. Determination of lipid peroxidation using malondialdehyde production assessment. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | |
Primary | Changes in protein carbonyls following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DNPH method. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | |
Primary | Changes in blood lipids following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | 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. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | |
Primary | Changes in insulin resistance 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. | Before and following 4 weeks of supplementation and placebo. | |
Primary | Changes in glycated hemoglobin (HbA1c) following 4 weeks of supplementation and placebo. | Measurement of HbA1c using commercially available kits. | Before and following 4 weeks of supplementation and placebo. | |
Secondary | Changes in body composition following 4 weeks of intervention and placebo. | Body fat mass (in kg) and percentage, lean mass (in kg) and percentage | Before and following 4 weeks of supplementation and placebo. | |
Secondary | Changes in body mass index following 4 weeks of intervention and placebo. | Body mass (in kg) and height (in cm) | Before and following 4 weeks of supplementation and placebo. | |
Secondary | Changes in resting heart rate following 4 weeks of intervention and placebo. | Resting heart rate (beats per minute) measurement after at least 5 minutes at rest | Before and following 4 weeks of supplementation and placebo. | |
Secondary | Changes in blood pressure following 4 weeks of intervention and placebo. | Measurement of (systolic and diastolic) blood pressure (in mm Hg) after at least 5 minutes at rest | Before and following 4 weeks of supplementation and placebo. | |
Secondary | Changes in waist-to-hip ratio following 4 weeks of intervention and placebo. | Measurement of waist and hip circumference to calculate waist-to-hip ratio | Before and following 4 weeks of supplementation and placebo. | |
Secondary | Changes in complete blood count following 4 weeks of intervention and placebo. | Complete blood count | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | |
Secondary | Changes in psychometric test following 4 weeks of intervention and placebo. | Hospital Anxiety Depression Scale-HADS (Greek version) | Before and following 4 weeks of supplementation and placebo. | |
Secondary | Trial of VO2peak estimation. | VO2peak (mL/kg body weight/min) estimation with a treadmill protocol. | Before intervention. | |
Secondary | Nicotinamide-adenine dinucleotide phosphate (NADPH) | Spectrophotometric assay for the determination of NADPH in erythrocytes. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | |
Secondary | Glutathione Reductase (GR) | Spectrophotometric assay for the determination of GR in erythrocytes. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | |
Secondary | Glutathione peroxidase (GPx) | Spectrophotometric assay for the determination of GPx in erythrocytes. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | |
Secondary | Superoxide dismutases (SOD) | Spectrophotometric assay for the determination of SOD in erythrocytes. | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | |
Secondary | Glucose Tolerance Test (GTT) | GTT for the investigation of changes in glucose control. | Before intervention (blood samples at 0, 30, 60, 90 and 120 minutes after intake of 75 g glucose). | |
Secondary | G6PD enzyme activity in erythrocytes | Quantification of G6PD activity in erythrocytes (units/gram of hemoglobin) of all participants using a commercially available kit. | 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). |
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