Oxidative Stress, Carbohydrate Metabolism Disorders and G6PD Deficiency

January 2, 2023 updated by: Athanasios Z. Jamurtas, University of Thessaly

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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:
  • Physical exercise
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:
  • Physical exercise
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:
  • Physical exercise
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:
  • Physical exercise
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:
  • Physical exercise
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:
  • Physical exercise
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:
  • Physical exercise
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:
  • Physical exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in total antioxidant capacity following 4 weeks of supplementation and placebo at rest and following a trial of acute exercise.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
Before and following 4 weeks of supplementation and placebo.
Changes in glycated hemoglobin (HbA1c) following 4 weeks of supplementation and placebo.
Time Frame: Before and following 4 weeks of supplementation and placebo.
Measurement of HbA1c using commercially available kits.
Before and following 4 weeks of supplementation and placebo.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body composition following 4 weeks of intervention and placebo.
Time Frame: Before and following 4 weeks of supplementation and placebo.
Body fat mass (in kg) and percentage, lean mass (in kg) and percentage
Before and following 4 weeks of supplementation and placebo.
Changes in body mass index following 4 weeks of intervention and placebo.
Time Frame: Before and following 4 weeks of supplementation and placebo.
Body mass (in kg) and height (in cm)
Before and following 4 weeks of supplementation and placebo.
Changes in resting heart rate following 4 weeks of intervention and placebo.
Time Frame: Before and following 4 weeks of supplementation and placebo.
Resting heart rate (beats per minute) measurement after at least 5 minutes at rest
Before and following 4 weeks of supplementation and placebo.
Changes in blood pressure following 4 weeks of intervention and placebo.
Time Frame: 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
Before and following 4 weeks of supplementation and placebo.
Changes in waist-to-hip ratio following 4 weeks of intervention and placebo.
Time Frame: Before and following 4 weeks of supplementation and placebo.
Measurement of waist and hip circumference to calculate waist-to-hip ratio
Before and following 4 weeks of supplementation and placebo.
Changes in complete blood count following 4 weeks of intervention and placebo.
Time Frame: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Complete blood count
Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Changes in psychometric test following 4 weeks of intervention and placebo.
Time Frame: Before and following 4 weeks of supplementation and placebo.
Hospital Anxiety Depression Scale-HADS (Greek version)
Before and following 4 weeks of supplementation and placebo.
Trial of VO2peak estimation.
Time Frame: Before intervention.
VO2peak (mL/kg body weight/min) estimation with a treadmill protocol.
Before intervention.
Nicotinamide-adenine dinucleotide phosphate (NADPH)
Time Frame: 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.
Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Glutathione Reductase (GR)
Time Frame: 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.
Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Glutathione peroxidase (GPx)
Time Frame: 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.
Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Superoxide dismutases (SOD)
Time Frame: 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.
Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Glucose Tolerance Test (GTT)
Time Frame: 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.
Before intervention (blood samples at 0, 30, 60, 90 and 120 minutes after intake of 75 g glucose).
G6PD enzyme activity in erythrocytes
Time Frame: 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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

May 28, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G6PD_Diabetes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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