G6PD DeficiencyNCT05571748
Oxidative Stress, Carbohydrate Metabolism Disorders and G6PD Deficiency
A study testing Alpha-lipoic acid in people with G6PD Deficiency and Carbohydrate Metabolism Disorder, run by University of Thessaly.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- G6PD Deficiency, Carbohydrate Metabolism Disorder, Oxidative Stress
- What is being tested?
- Alpha-lipoic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- Alpha-lipoic acid, Placebo
- Medical subject headings
- Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-lipoic acidDietary supplement
Also called Physical exercise
A trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation.
PlaceboOther
Also called Physical exercise
A trial of acute exercise before and after 4 weeks of placebo supplementation.
| Study group | Role | What they receive |
|---|---|---|
| G6PD deficiency (only) - Intervention | Experimental | Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 G6PD deficient individuals. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and following 4 weeks of supplementation and placebo.
Secondary outcomes (14)
Changes in body composition following 4 weeks of intervention and placebo.
Body fat mass (in kg) and percentage, lean mass (in kg) and percentage
Measured: Before and following 4 weeks of supplementation and placebo.
Changes in body mass index following 4 weeks of intervention and placebo.
Body mass (in kg) and height (in cm)
Measured: Before and following 4 weeks of supplementation and placebo.
Changes in resting heart rate following 4 weeks of intervention and placebo.
Resting heart rate (beats per minute) measurement after at least 5 minutes at rest
Measured: Before and following 4 weeks of supplementation and placebo.
Changes in blood pressure following 4 weeks of intervention and placebo.
Measurement of (systolic and diastolic) blood pressure (in mm Hg) after at least 5 minutes at rest
Measured: Before and following 4 weeks of supplementation and placebo.
Changes in waist-to-hip ratio following 4 weeks of intervention and placebo.
Measurement of waist and hip circumference to calculate waist-to-hip ratio
Measured: Before and following 4 weeks of supplementation and placebo.
Changes in complete blood count following 4 weeks of intervention and placebo.
Complete blood count
Measured: 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.
Hospital Anxiety Depression Scale-HADS (Greek version)
Measured: Before and following 4 weeks of supplementation and placebo.
Trial of VO2peak estimation.
VO2peak (mL/kg body weight/min) estimation with a treadmill protocol.
Measured: Before intervention.
Nicotinamide-adenine dinucleotide phosphate (NADPH)
Spectrophotometric assay for the determination of NADPH in erythrocytes.
Measured: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Glutathione Reductase (GR)
Spectrophotometric assay for the determination of GR in erythrocytes.
Measured: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Glutathione peroxidase (GPx)
Spectrophotometric assay for the determination of GPx in erythrocytes.
Measured: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Superoxide dismutases (SOD)
Spectrophotometric assay for the determination of SOD in erythrocytes.
Measured: Before, immediately after and 1 hour after each trial of exercise, in both conditions (supplement and placebo)
Glucose Tolerance Test (GTT)
GTT for the investigation of changes in glucose control.
Measured: Before intervention (blood samples at 0, 30, 60, 90 and 120 minutes after intake of 75 g glucose).
G6PD enzyme activity in erythrocytes
Quantification of G6PD activity in erythrocytes (units/gram of hemoglobin) of all participants using a commercially available kit.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study startFeb 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for G6PD DeficiencyStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athanasios Z. Jamurtas, University of Thessaly
- Investigators
- Athanasios Z Jamurtas, PhD, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571748
- Sponsor's protocol ID
- G6PD_Diabetes
- Status last verified
- Jan 2023
- First submitted
- 28 May 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23416142
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Oxidative Stress and Carbohydrate Metabolism Disorders in G6PD Deficient Individuals
- ClinicalTrials.gov ID
- NCT05571748
- Acronym / sponsor ID
- G6PD_Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| G6PD deficiency (only) - Intervention | Experimental | Dietary Supplement: Alpha-lipoic acidAlpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 G6PD deficient individuals. |
| G6PD deficiency (only) - Placebo | Placebo comparator | Other: PlaceboPlacebo administration for 4 weeks in a counterbalanced manner to 120 G6PD deficient individuals. |
| G6PD deficiency and CHO metabolism disorder - Intervention | Experimental | Dietary Supplement: Alpha-lipoic acidAlpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 individuals with G6PD deficiency and a CHO metabolism disorder. |
| G6PD deficiency and CHO metabolism disorder - Placebo | Placebo comparator | Other: PlaceboPlacebo for 4 weeks in a counterbalanced manner to 10 individuals with G6PD deficiency and a CHO metabolism disorder. |
| CHO metabolism disorder (only) - Intervention | Experimental | Dietary Supplement: Alpha-lipoic acidAlpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 10 individuals with a CHO metabolism disorder. |
| CHO metabolism disorder (only) - Placebo | Placebo comparator | Other: PlaceboPlacebo for 4 weeks in a counterbalanced manner to 10 individuals with a CHO metabolism disorder. |
| Controls - Intervention | Experimental | Dietary Supplement: Alpha-lipoic acidAlpha-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. |
| Controls - Placebo | Placebo comparator | Other: PlaceboPlacebo for 4 weeks in a counterbalanced manner to 10 individuals without G6PD deficiency and/or any CHO metabolism disorder. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-lipoic acidAlso: Physical exerciseA trial of acute exercise before and after 4 weeks of alpha-lipoic acid supplementation. | Dietary supplement | CHO metabolism disorder (only) - Intervention, Controls - Intervention, G6PD deficiency (only) - Intervention, G6PD deficiency and CHO metabolism disorder - Intervention |
| PlaceboAlso: Physical exerciseA trial of acute exercise before and after 4 weeks of placebo supplementation. | Other | CHO metabolism disorder (only) - Placebo, Controls - Placebo, G6PD deficiency (only) - Placebo, G6PD deficiency and CHO metabolism disorder - Placebo |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
14 secondary outcomes
Changes in body composition following 4 weeks of intervention and placebo.
Time frame: 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.
Changes in resting heart rate following 4 weeks of intervention and placebo.
Time frame: 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.
Changes in waist-to-hip ratio following 4 weeks of intervention and placebo.
Time frame: 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)
Changes in psychometric test following 4 weeks of intervention and placebo.
Time frame: Before and following 4 weeks of supplementation and placebo.
Trial of VO2peak estimation.
Time frame: 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)
Glutathione Reductase (GR)
Time frame: 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)
Superoxide dismutases (SOD)
Time frame: 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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Background: PubMed 23416142Georgakouli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanasios Z Jamurtas, PhD study director
University of Thessaly
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-lipoic acid in people with G6PD Deficiency and Carbohydrate Metabolism Disorder, run by University of Thessaly.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Athanasios Z Jamurtas, PhD (2431047054 ext. +30, ajamurt@pe.uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05571748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.