Oxidative Stress, Carbohydrate Metabolism Disorders and G6PD Deficiency
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: G6PD deficiency (only) - Intervention Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 G6PD deficient individuals. |
Dietary Supplement: Alpha-lipoic acid
A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation.
Other Names:
|
| Placebo Comparator: G6PD deficiency (only) - Placebo Placebo administration for 4 weeks in a counterbalanced manner to 120 G6PD deficient individuals. |
Other: Placebo
A trial of acute exercise before and after 4 weeks of placebo supplementation.
Other Names:
|
| Experimental: G6PD deficiency and CHO metabolism disorder - Intervention Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 individuals with G6PD deficiency and a CHO metabolism disorder. |
Dietary Supplement: Alpha-lipoic acid
A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation.
Other Names:
|
| Placebo Comparator: G6PD deficiency and CHO metabolism disorder - Placebo Placebo for 4 weeks in a counterbalanced manner to 10 individuals with G6PD deficiency and a CHO metabolism disorder. |
Other: Placebo
A trial of acute exercise before and after 4 weeks of placebo supplementation.
Other Names:
|
| Experimental: CHO metabolism disorder (only) - Intervention Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 individuals with a CHO metabolism disorder. |
Dietary Supplement: Alpha-lipoic acid
A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation.
Other Names:
|
| Placebo Comparator: CHO metabolism disorder (only) - Placebo Placebo for 4 weeks in a counterbalanced manner to 10 individuals with a CHO metabolism disorder. |
Other: Placebo
A trial of acute exercise before and after 4 weeks of placebo supplementation.
Other Names:
|
| Experimental: Controls - Intervention Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 individuals without G6PD deficiency and/or any CHO metabolism disorder. |
Dietary Supplement: Alpha-lipoic acid
A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation.
Other Names:
|
| Placebo Comparator: Controls - Placebo Placebo for 4 weeks in a counterbalanced manner to 10 individuals without G6PD deficiency and/or any CHO metabolism disorder. |
Other: Placebo
A trial of acute exercise before and after 4 weeks of placebo supplementation.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Thessaly
Investigators
- Study Director: Athanasios Z Jamurtas, PhD, University of Thessaly
Study Documents (Full-Text)
None provided.More Information
Publications
- G6PD_Diabetes