Oxidative Stress, Carbohydrate Metabolism Disorders and G6PD Deficiency

University of Thessaly

Status: Not yet enrolling

Conditions: G6PD Deficiency; Carbohydrate Metabolism Disorder; Oxidative Stress

Treatments: Other: Placebo; Dietary Supplement: Alpha-lipoic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05571748

G6PD_Diabetes

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 8 patient groups, including a placebo group

G6PD deficiency (only) - Intervention

Experimental group

Description:

Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 G6PD deficient individuals.

Treatment:

Dietary Supplement: Alpha-lipoic acid

G6PD deficiency (only) - Placebo

Placebo Comparator group

Description:

Placebo administration for 4 weeks in a counterbalanced manner to 120 G6PD deficient individuals.

Treatment:

Other: Placebo

G6PD deficiency and CHO metabolism disorder - Intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Alpha-lipoic acid

G6PD deficiency and CHO metabolism disorder - Placebo

Placebo Comparator group

Description:

Placebo for 4 weeks in a counterbalanced manner to 10 individuals with G6PD deficiency and a CHO metabolism disorder.

Treatment:

Other: Placebo

CHO metabolism disorder (only) - Intervention

Experimental group

Description:

Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 individuals with a CHO metabolism disorder.

Treatment:

Dietary Supplement: Alpha-lipoic acid

CHO metabolism disorder (only) - Placebo

Placebo Comparator group

Description:

Placebo for 4 weeks in a counterbalanced manner to 10 individuals with a CHO metabolism disorder.

Treatment:

Other: Placebo

Controls - Intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Alpha-lipoic acid

Controls - Placebo

Placebo Comparator group

Description:

Placebo for 4 weeks in a counterbalanced manner to 10 individuals without G6PD deficiency and/or any CHO metabolism disorder.

Treatment:

Other: Placebo