The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin (HbA1c) Levels in Type 2 Diabetes Patients - Trial NCT06313164
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.
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Study Focus
Sponsor & Location
S.LAB (SOLOWAYS)
Timeline & Enrollment
N/A
Jun 20, 2023
Feb 29, 2024
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
Data Source
ClinicalTrials.gov
NCT06313164
Non-Device Trial