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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
S.LAB (SOLOWAYS)ClinicalTrials.govdietary supplement
Study focus
Disease/Condition
Type 2 Diabetes
Drug/Device/Intervention
enhanced glutathione
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
S.LAB (SOLOWAYS)
Location
Novosibirsk, Russian Federation
Timeline & enrollment
Phase
N/A
Start date
Jun 20, 2023
End date
Feb 29, 2024
Enrollment
217 participants
Primary outcome

Reduced glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus

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). 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.

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06313164
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06313164 through Pure Global AI's free database. This phase not specified trial is sponsored by S.LAB (SOLOWAYS) and is currently Completed. The study focuses on Type 2 Diabetes. Target enrollment is 217 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.