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Completed

NCT Number: NCT06313164

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

enhanced glutathione

Dietary Supplement

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

Placebo Comparator

Other

placebo group

Primary outcomes

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

    Time frame: 180 days

Secondary outcomes

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

    Time frame: 180 days

  2. 8-Oxoguanine (8-OHdG) Levels Change in Patients with Type 2 Diabetes Mellitus

    Time frame: 180 days

  3. Glycated Hemoglobin Concentration (HbA1c) Change in Patients with Type 2 Diabetes Mellitus

    Time frame: 180 days

  4. Fasting Glucose (FPG) Levels Change in Patients with Type 2 Diabetes Mellitus

    Time frame: 180 days

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

    Time frame: 180 days

  6. Fasting Insulin (FPI) Levels Change in Patients with Type 2 Diabetes Mellitus

    Time frame: 180 days

  7. Postprandial Insulin (PPI) Levels Change in Patients with Type 2 Diabetes Mellitus

    Time frame: 180 days

Sponsors and collaborators

Lead sponsor

S.LAB (SOLOWAYS)

Other

Collaborators

  • Center of New Medical Technologies

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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