NCT06313164

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

March 10, 2024

Last Update Submit

March 24, 2025

Conditions

Type 2 Diabetes

Keywords

oxidative stressglutathioneantioxidantspreventive supplementation

Outcome Measures

Primary Outcomes (1)

  • Сhanged glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus

    180 days

Secondary Outcomes (7)

  • Oxidized Glutathione (GSSG) Levels Change in Patients with Type 2 Diabetes Mellitus

    180 days

  • 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

  • Postprandial Glucose (PPG) Levels Change in Patients with Type 2 Diabetes Mellitus

    180 days

  • +2 more secondary outcomes

Study Arms (2)

enhanced L-gluthathione group

EXPERIMENTAL
Dietary Supplement: enhanced glutathione

placebo group

PLACEBO COMPARATOR
Other: placebo comparator

Interventions

enhanced glutathioneDIETARY_SUPPLEMENT

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

enhanced L-gluthathione group
placebo comparatorOTHER

placebo group

placebo group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2024

First Posted

March 15, 2024

Study Start

June 20, 2023

Primary Completion

January 30, 2024

Study Completion

February 29, 2024

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

RU(1)