Clinical trial NCT06313164: The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin (HbA1c) Levels in Type 2 Diabetes Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: oxidative stress
glutathione
antioxidants
preventive supplementation
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Center of New Medical Technologies
First posted: 2024-03-15
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Сhanged glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus
timeFrame: 180 days
Secondary outcomes:
measure: Oxidized Glutathione (GSSG) Levels Change in Patients with Type 2 Diabetes Mellitus
timeFrame: 180 days
measure: 8-Oxoguanine (8-OHdG) Levels Change in Patients with Type 2 Diabetes Mellitus
timeFrame: 180 days
measure: Glycated Hemoglobin Concentration (HbA1c) Change in Patients with Type 2 Diabetes Mellitus
timeFrame: 180 days
measure: Fasting Glucose (FPG) Levels Change in Patients with Type 2 Diabetes Mellitus
timeFrame: 180 days
measure: Postprandial Glucose (PPG) Levels Change in Patients with Type 2 Diabetes Mellitus
timeFrame: 180 days
measure: Fasting Insulin (FPI) Levels Change in Patients with Type 2 Diabetes Mellitus
timeFrame: 180 days
measure: Postprandial Insulin (PPI) Levels Change in Patients with Type 2 Diabetes Mellitus
timeFrame: 180 days
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibisk Region
Study officials:
References: