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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
217
L-glutathione (in combination with tannin, low molecular weight chitosan and polyethylene glycol)
placebo group
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, Russia
Сhanged glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus
Time frame: 180 days
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
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