Type 2 DiabetesNCT06313164
The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin (HbA1c) Levels in Type 2 Diabetes Patients
A study testing enhanced glutathione in people with Type 2 Diabetes, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial summary
This trial aims to assess the effectiveness of L-glutathione, supplemented with bioavailability boosters (tannin, low molecular weight chitosan, and polyethylene glycol), on improving antioxidant levels and glycemic control in patients with type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- enhanced glutathione
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 1 siteRussia
- Study dates
- 20 Jun 2023to 29 Feb 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects with diabetes mellitus type 2 with confirmed levels of glycated hemoglobin (HbA1c) ≥ 6.5%
Who cannot join
- pregnancy and breastfeeding
- heavy smoking: Individuals consuming more than 20 cigarettes per day;
- excessive alcohol consumption: Participants who consume alcohol in excess of established limits, defined as more than 14 standart doses for men and 7 for woman;
- active clinical infections
- recent cardiovascular events: Individuals who suffered from cardiovascular event in the last 6 months;
- subjects receiving antioxidant drugs or dietary supplements;
Trial locations and contacts
1 site in 1 country.
Russia1 site
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, 630090
About this study
Official title: The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin (HbA1c) Levels in Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Study
This trial aims to assess the effectiveness of L-glutathione, supplemented with bioavailability boosters (tannin, low molecular weight chitosan, and polyethylene glycol), on improving antioxidant levels and glycemic control in patients with type 2 diabetes (T2D). The study is designed as a randomized, double-blind, placebo-controlled trial intending to enroll 240 T2D patients. The primary objective is to measure changes from baseline to 180 days in several key biomarkers, including endogenous reduced glutathione (GSH), oxidized glutathione (GSSG), 8-hydroxydeoxyguanosine (8-OHdG), and glycated hemoglobin (HbA1c), along with other metabolic parameters.
Hypothesis: The anticipated outcome is a significant increase in GSH levels and a decrease in markers of oxidative damage among participants receiving L-glutathione compared to those in the placebo group, potentially indicating improved antioxidant defenses and some effects on glycemic regulation in T2D patients. This trial aims to fill gaps in current research regarding the role of L-glutathione supplementation in managing oxidative stress and metabolic control in diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- enhanced glutathione, placebo comparator
- Keywords
- oxidative stress, glutathione, antioxidants, preventive supplementation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced glutathioneDietary supplement
L-glutathione (in combination with tannin, low molecular weight chitosan and polyethylene glycol)
placebo comparatorOther
placebo group
| Study group | Role | What they receive |
|---|---|---|
| enhanced L-gluthathione group | Experimental | Not described Receives: Dietary Supplement: enhanced glutathione |
| placebo group | Placebo comparator | Not described Receives: Other: placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Сhanged glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus
Measured: 180 days
Secondary outcomes (7)
Oxidized Glutathione (GSSG) Levels Change in Patients with Type 2 Diabetes Mellitus
Measured: 180 days
8-Oxoguanine (8-OHdG) Levels Change in Patients with Type 2 Diabetes Mellitus
Measured: 180 days
Glycated Hemoglobin Concentration (HbA1c) Change in Patients with Type 2 Diabetes Mellitus
Measured: 180 days
Fasting Glucose (FPG) Levels Change in Patients with Type 2 Diabetes Mellitus
Measured: 180 days
Postprandial Glucose (PPG) Levels Change in Patients with Type 2 Diabetes Mellitus
Measured: 180 days
Fasting Insulin (FPI) Levels Change in Patients with Type 2 Diabetes Mellitus
Measured: 180 days
Postprandial Insulin (PPI) Levels Change in Patients with Type 2 Diabetes Mellitus
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start20 Jun 2023
- Primary completion30 Jan 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center of New Medical Technologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313164
- Sponsor's protocol ID
- SW009
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin (HbA1c) Levels in Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT06313164
- Acronym / sponsor ID
- SW009
- Conditions
- Type 2 Diabetes
- Keywords
- oxidative stress, glutathione, antioxidants, preventive supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center of New Medical Technologies
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 15 Mar 2024 (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.
This trial aims to assess the effectiveness of L-glutathione, supplemented with bioavailability boosters (tannin, low molecular weight chitosan, and polyethylene glycol), on improving antioxidant levels and glycemic control in patients with type 2 diabetes (T2D). The study is designed as a randomized, double-blind, placebo-controlled trial intending to enroll 240 T2D patients. The primary objective is to measure changes from baseline to 180 days in several key biomarkers, including endogenous reduced glutathione (GSH), oxidized glutathione (GSSG), 8-hydroxydeoxyguanosine (8-OHdG), and glycated hemoglobin (HbA1c), along with other metabolic parameters.
Hypothesis: The anticipated outcome is a significant increase in GSH levels and a decrease in markers of oxidative damage among participants receiving L-glutathione compared to those in the placebo group, potentially indicating improved antioxidant defenses and some effects on glycemic regulation in T2D patients. This trial aims to fill gaps in current research regarding the role of L-glutathione supplementation in managing oxidative stress and metabolic control in diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enhanced L-gluthathione group | Experimental | Dietary Supplement: enhanced glutathione |
| placebo group | Placebo comparator | Other: placebo comparator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects with diabetes mellitus type 2 with confirmed levels of glycated hemoglobin (HbA1c) ≥ 6.5%
Key exclusion criteria (6 listed)
- pregnancy and breastfeeding
- heavy smoking: Individuals consuming more than 20 cigarettes per day;
- excessive alcohol consumption: Participants who consume alcohol in excess of established limits, defined as more than 14 standart doses for men and 7 for woman;
- active clinical infections
- recent cardiovascular events: Individuals who suffered from cardiovascular event in the last 6 months;
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 |
|---|---|---|
| enhanced glutathioneL-glutathione (in combination with tannin, low molecular weight chitosan and polyethylene glycol) | Dietary supplement | enhanced L-gluthathione group |
| placebo comparatorplacebo group | Other | placebo group |
Primary outcome
Сhanged glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus
Time frame: 180 days
7 secondary outcomes
Oxidized Glutathione (GSSG) Levels Change in Patients with Type 2 Diabetes Mellitus
Time frame: 180 days
8-Oxoguanine (8-OHdG) Levels Change in Patients with Type 2 Diabetes Mellitus
Time frame: 180 days
Glycated Hemoglobin Concentration (HbA1c) Change in Patients with Type 2 Diabetes Mellitus
Time frame: 180 days
Fasting Glucose (FPG) Levels Change in Patients with Type 2 Diabetes Mellitus
Time frame: 180 days
Postprandial Glucose (PPG) Levels Change in Patients with Type 2 Diabetes Mellitus
Time frame: 180 days
Fasting Insulin (FPI) Levels Change in Patients with Type 2 Diabetes Mellitus
Time frame: 180 days
Postprandial Insulin (PPI) Levels Change in Patients with Type 2 Diabetes Mellitus
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced glutathione in people with Type 2 Diabetes, run by S.LAB (SOLOWAYS) at 1 site in Russia.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Сhanged glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2025.