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

What Was Tested

In this not phased trial, researchers set out to test Glutathione.

The study is designed as a randomized, double-blind, placebo-controlled trial intending to enroll 240 T2D patients.

It had two arms (groups): enhanced L-gluthathione group (experimental) and placebo group (placebo comparator).

The registry classes the interventions as dietary supplement and other.

Who Took Part

The registry lists 217 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: pregnancy and breastfeeding; heavy smoking: individuals consuming more than 20 cigarettes per day;; active clinical infections.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this Glutathione study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Glutathione group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Glutathione, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2023-06-20 with completion listed for 2024-01-30.

It ran at 1 site in Russia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Сhanged glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus (time frame: 180 days).

It also tracked 7 secondary outcomes, for example Oxidized Glutathione (GSSG) Levels Change in Patients with Type 2 Diabetes Mellitus, 8-Oxoguanine (8-OHdG) Levels Change in Patients with Type 2 Diabetes Mellitus, Glycated Hemoglobin Concentration (HbA1c) Change in Patients with Type 2 Diabetes Mellitus, Fasting Glucose (FPG) Levels Change in Patients with Type 2 Diabetes Mellitus, Postprandial Glucose (PPG) Levels Change in Patients with Type 2 Diabetes Mellitus and Fasting Insulin (FPI) Levels Change in Patients with Type 2 Diabetes Mellitus.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 217 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, all human trials.