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

NCT ID: NCT06313164

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-20

Study Completion Date

2024-02-29

Brief Summary

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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

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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enhanced L-gluthathione group

Group Type EXPERIMENTAL

enhanced glutathione

Intervention Type DIETARY_SUPPLEMENT

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

placebo group

Group Type PLACEBO_COMPARATOR

placebo comparator

Intervention Type OTHER

placebo group

Interventions

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enhanced glutathione

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

Intervention Type DIETARY_SUPPLEMENT

placebo comparator

placebo group

Intervention Type OTHER

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center of New Medical Technologies

OTHER

Sponsor Role collaborator

S.LAB (SOLOWAYS)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Center of New Medical Technologies

Novosibirsk, Novosibisk Region, Russia

Site Status

Countries

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Russia

Other Identifiers

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SW009

Identifier Type: -

Identifier Source: org_study_id

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