NCT06313164Completed
The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin (HbA1c) Levels in Type 2 Diabetes Patients
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
Source: ClinicalTrials.gov · Last updated 27 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 217 (actual)
- First submitted
- 10 Mar 2024
- Start date
- 20 Jun 2023
- Primary completion date
- 30 Jan 2024
- Lead sponsor
- S.LAB (SOLOWAYS)
- Diseases
- Type 2 diabetes
- NCT number
- NCT06313164
What you commit to
- Study type: Interventional
- Participants enrolled: 217
- From 20 Jun 2023 to the primary completion date, 30 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- subjects receiving antioxidant drugs or dietary supplements;
Other illness
- active clinical infections
Other
- 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;
- recent cardiovascular events: Individuals who suffered from cardiovascular event in the last 6 months;
Who the study is looking for
- subjects with diabetes mellitus type 2 with confirmed levels of glycated hemoglobin (HbA1c) ≥ 6.5%
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center of New Medical Technologies Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.