NCT05571748

Oxidative Stress, Carbohydrate Metabolism Disorders and G6PD Deficiency

The Association Between Oxidative Stress and Carbohydrate Metabolism Disorders in G6PD Deficient Individuals

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Thessaly · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• G6PD Deficiency
• Carbohydrate Metabolism Disorder
• Oxidative Stress

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Alpha-lipoic acid	A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation.
OTHER	Placebo	A trial of acute exercise before and after 4 weeks of placebo supplementation.

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-03-01
• Completion: 2023-06-01
• First posted: 2022-10-07
• Last updated: 2023-01-04