Clinical trial NCT05571748: Oxidative Stress, Carbohydrate Metabolism Disorders and G6PD Deficiency
Official title: The Association Between Oxidative Stress and Carbohydrate Metabolism Disorders in G6PD Deficient Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: G6PD Deficiency
Carbohydrate Metabolism Disorder
Oxidative Stress
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Changes in total antioxidant capacity following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
timeFrame: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
measure: Changes in glutathione following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
timeFrame: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
measure: Changes in uric acid following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
timeFrame: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
measure: Changes in bilirubin following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
timeFrame: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
measure: Changes in lipid peroxidation following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
timeFrame: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
measure: Changes in protein carbonyls following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
timeFrame: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
measure: Changes in blood lipids following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
timeFrame: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
measure: Changes in insulin resistance following 4 weeks of supplementation and placebo.
timeFrame: Before and following 4 weeks of supplementation and placebo.
measure: Changes in glycated hemoglobin (HbA1c) following 4 weeks of supplementation and placebo.
timeFrame: Before and following 4 weeks of supplementation and placebo.
Secondary outcomes:
measure: Changes in body composition following 4 weeks of intervention and placebo.
timeFrame: Before and following 4 weeks of supplementation and placebo.
measure: Changes in body mass index following 4 weeks of intervention and placebo.
timeFrame: Before and following 4 weeks of supplementation and placebo.
measure: Changes in resting heart rate following 4 weeks of intervention and placebo.
timeFrame: Before and following 4 weeks of supplementation and placebo.
measure: Changes in blood pressure following 4 weeks of intervention and placebo.
timeFrame: Before and following 4 weeks of supplementation and placebo.
measure: Changes in waist-to-hip ratio following 4 weeks of intervention and placebo.
timeFrame: Before and following 4 weeks of supplementation and placebo.
measure: Changes in complete blood count following 4 weeks of intervention and placebo.
timeFrame: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
measure: Changes in psychometric test following 4 weeks of intervention and placebo.
timeFrame: Before and following 4 weeks of supplementation and placebo.
measure: Trial of VO2peak estimation.
timeFrame: Before intervention.
measure: Nicotinamide-adenine dinucleotide phosphate (NADPH)
timeFrame: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
measure: Glutathione Reductase (GR)
timeFrame: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
measure: Glutathione peroxidase (GPx)
timeFrame: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
measure: Superoxide dismutases (SOD)
timeFrame: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
measure: Glucose Tolerance Test (GTT)
timeFrame: Before intervention (blood samples at 0, 30, 60, 90 and 120 minutes after intake of 75 g glucose).
measure: G6PD enzyme activity in erythrocytes
timeFrame: 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).
Other outcomes:
Locations:
Study officials:
affiliation: University of Thessaly
name: Athanasios Z Jamurtas, PhD
role: STUDY_DIRECTOR
References:
citation: 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.