G6PD Deficiency, Carbohydrate Metabolism Disorder, Oxidative Stress
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTAlpha-lipoic acid
A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation.
OTHERPlacebo
A trial of acute exercise before and after 4 weeks of placebo supplementation.
Sponsors
University of Thessaly
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in total antioxidant capacity following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | 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 glutathione following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | 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 uric acid following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | 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 bilirubin following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | 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 lipid peroxidation following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | 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 protein carbonyls following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | 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 blood lipids following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise. | 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. | 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. | Before and following 4 weeks of supplementation and placebo. | Measurement of HbA1c using commercially available kits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glutathione Reductase (GR) | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | Spectrophotometric assay for the determination of GR in erythrocytes. |
| Glutathione peroxidase (GPx) | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | Spectrophotometric assay for the determination of GPx in erythrocytes. |
| Changes in body composition following 4 weeks of intervention and placebo. | Before and following 4 weeks of supplementation and placebo. | Body fat mass (in kg) and percentage, lean mass (in kg) and percentage |
| Glucose Tolerance Test (GTT) | Before intervention (blood samples at 0, 30, 60, 90 and 120 minutes after intake of 75 g glucose). | GTT for the investigation of changes in glucose control. |
| 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). | Quantification of G6PD activity in erythrocytes (units/gram of hemoglobin) of all participants using a commercially available kit. |
| Superoxide dismutases (SOD) | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | Spectrophotometric assay for the determination of SOD in erythrocytes. |
| Changes in body mass index following 4 weeks of intervention and placebo. | Before and following 4 weeks of supplementation and placebo. | Body mass (in kg) and height (in cm) |
| Changes in resting heart rate following 4 weeks of intervention and placebo. | Before and following 4 weeks of supplementation and placebo. | Resting heart rate (beats per minute) measurement after at least 5 minutes at rest |
| Changes in blood pressure following 4 weeks of intervention and placebo. | Before and following 4 weeks of supplementation and placebo. | Measurement of (systolic and diastolic) blood pressure (in mm Hg) after at least 5 minutes at rest |
| Changes in waist-to-hip ratio following 4 weeks of intervention and placebo. | Before and following 4 weeks of supplementation and placebo. | Measurement of waist and hip circumference to calculate waist-to-hip ratio |
| 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) | Complete blood count |
| Changes in psychometric test following 4 weeks of intervention and placebo. | Before and following 4 weeks of supplementation and placebo. | Hospital Anxiety Depression Scale-HADS (Greek version) |
| Trial of VO2peak estimation. | Before intervention. | VO2peak (mL/kg body weight/min) estimation with a treadmill protocol. |
| Nicotinamide-adenine dinucleotide phosphate (NADPH) | Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo) | Spectrophotometric assay for the determination of NADPH in erythrocytes. |
Contacts
Primary ContactAthanasios Z Jamurtas, PhD
Backup ContactAthanasios Gatsas, MSc
Outcome results
None listed