The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin (HbA1c) Levels in Type 2 Diabetes Patients

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: enhanced glutathione; Other: placebo comparator

• Registration Number: NCT06313164
• Lead Sponsor: S.LAB (SOLOWAYS)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-20
• Primary Completion: 2024-01-30
• Study Completion: 2024-02-29
• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

• subjects with diabetes mellitus type 2 with confirmed levels of glycated hemoglobin (HbA1c) ≥ 6.5%

Exclusion Criteria

• 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enhanced L-gluthathione group	enhanced glutathione	-
placebo group	placebo comparator	-

Primary Outcome Measures

Name	Time	Method
Сhanged glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus	180 days

Secondary Outcome Measures

Name	Time	Method
8-Oxoguanine (8-OHdG) Levels Change in Patients with Type 2 Diabetes Mellitus	180 days
Glycated Hemoglobin Concentration (HbA1c) Change in Patients with Type 2 Diabetes Mellitus	180 days
Postprandial Insulin (PPI) Levels Change in Patients with Type 2 Diabetes Mellitus	180 days
Oxidized Glutathione (GSSG) Levels Change in Patients with Type 2 Diabetes Mellitus	180 days
Fasting Insulin (FPI) Levels Change in Patients with Type 2 Diabetes Mellitus	180 days
Fasting Glucose (FPG) Levels Change in Patients with Type 2 Diabetes Mellitus	180 days
Postprandial Glucose (PPG) Levels Change in Patients with Type 2 Diabetes Mellitus	180 days

Trial Locations

Locations (1)

Center of New Medical Technologies; 🇷🇺 Novosibirsk, Novosibisk Region, Russian Federation