Oxidative Stress, Carbohydrate Metabolism Disorders and G6PD Deficiency

NCT05571748 | Unknown

• 1 other identifier: G6PD_Diabetes
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

G6PD Deficiency; Carbohydrate Metabolism Disorder; Oxidative Stress

Outcome Measures

Primary Outcomes (9)

• Changes in total antioxidant capacity following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.

  Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DPPH method.

  Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)

• Changes in glutathione following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.

  Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DTNB method.

  Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)

• Changes in uric acid following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.

  Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using a clinical chemistry analyzer with commercially available kits.

  Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)

• Changes in bilirubin following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.

  Index of blood redox status. Spectrophotometric assay for the determination of bilirubin using a clinical chemistry analyzer with commercially available kits.

  Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)

• Changes in lipid peroxidation following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.

  Index of blood redox status. Determination of lipid peroxidation using malondialdehyde production assessment.

  Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)

• Changes in protein carbonyls following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.

  Index of blood redox status. Spectrophotometric assay for the determination of total antioxidant capacity using DNPH method.

  Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)

• Changes in blood lipids following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.

  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.

  Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)

• Changes in insulin resistance 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.

  Before and following 4 weeks of supplementation and placebo.

• Changes in glycated hemoglobin (HbA1c) following 4 weeks of supplementation and placebo.

  Measurement of HbA1c using commercially available kits.

  Before and following 4 weeks of supplementation and placebo.

Secondary Outcomes (14)

• Changes in body composition following 4 weeks of intervention and placebo.

  Before and following 4 weeks of supplementation and placebo.

• Changes in body mass index following 4 weeks of intervention and placebo.

  Before and following 4 weeks of supplementation and placebo.

• Changes in resting heart rate following 4 weeks of intervention and placebo.

  Before and following 4 weeks of supplementation and placebo.

• Changes in blood pressure following 4 weeks of intervention and placebo.

  Before and following 4 weeks of supplementation and placebo.

• Changes in waist-to-hip ratio following 4 weeks of intervention and placebo.

  Before and following 4 weeks of supplementation and placebo.

Study Arms (8)

G6PD deficiency (only) - Intervention

EXPERIMENTAL

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

Dietary Supplement: Alpha-lipoic acid

G6PD deficiency (only) - Placebo

PLACEBO COMPARATOR

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

Other: Placebo

G6PD deficiency and CHO metabolism disorder - Intervention

EXPERIMENTAL

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

G6PD deficiency and CHO metabolism disorder - Placebo

PLACEBO COMPARATOR

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

Other: Placebo

CHO metabolism disorder (only) - Intervention

EXPERIMENTAL

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

CHO metabolism disorder (only) - Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Controls - Intervention

EXPERIMENTAL

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

Controls - Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Alpha-lipoic acid DIETARY_SUPPLEMENT

A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation.

Also known as: Physical exercise

CHO metabolism disorder (only) - Intervention; Controls - Intervention; G6PD deficiency (only) - Intervention; G6PD deficiency and CHO metabolism disorder - Intervention

Placebo OTHER

A trial of acute exercise before and after 4 weeks of placebo supplementation.

Also known as: Physical exercise

CHO metabolism disorder (only) - Placebo; Controls - Placebo; G6PD deficiency (only) - Placebo; G6PD deficiency and CHO metabolism disorder - Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

Related Publications (1)

• 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.

  PMID: 23416142 BACKGROUND

MeSH Terms

Conditions

Glucosephosphate Dehydrogenase Deficiency

Interventions

Thioctic Acid; Exercise

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Athanasios Z Jamurtas, PhD

  University of Thessaly

  STUDY DIRECTOR

Central Study Contacts

Athanasios Z Jamurtas, PhD

CONTACT

2431047054; ajamurt@pe.uth.gr

Athanasios Gatsas, MSc

CONTACT

6971559250; t.gatsas@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2022
• First Posted: October 7, 2022
• Study Start: February 1, 2023
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 4, 2023

Record last verified: 2023-01