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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06313164

Enrollment

217

Registered

2024-03-15

Start date

2023-06-20

Completion date

2024-02-29

Last updated

2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

oxidative stress, glutathione, antioxidants, preventive supplementation

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.

Interventions

DIETARY_SUPPLEMENTenhanced glutathione

L-glutathione (in combination with tannin, low molecular weight chitosan and polyethylene glycol)

OTHERplacebo comparator

placebo group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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;

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Fasting Glucose (FPG) 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
Postprandial Insulin (PPI) 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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026