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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06313164
• Other study ID #: SW009
• Status: Completed
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: S.LAB (SOLOWAYS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: February 29, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• enhanced glutathione
L-glutathione (in combination with tannin, low molecular weight chitosan and polyethylene glycol)

Other:
• placebo comparator
placebo group

Locations

Country	Name	City	State
Russian Federation	Center of New Medical Technologies	Novosibirsk	Novosibisk Region

Sponsors (2)

Lead Sponsor	Collaborator
S.LAB (SOLOWAYS)	Center of New Medical Technologies

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus		180 days
Secondary	Oxidized Glutathione (GSSG) Levels Change in Patients with Type 2 Diabetes Mellitus		180 days
Secondary	8-Oxoguanine (8-OHdG) Levels Change in Patients with Type 2 Diabetes Mellitus		180 days
Secondary	Glycated Hemoglobin Concentration (HbA1c) Change in Patients with Type 2 Diabetes Mellitus		180 days
Secondary	Fasting Glucose (FPG) Levels Change in Patients with Type 2 Diabetes Mellitus		180 days
Secondary	Postprandial Glucose (PPG) Levels Change in Patients with Type 2 Diabetes Mellitus		180 days
Secondary	Fasting Insulin (FPI) Levels Change in Patients with Type 2 Diabetes Mellitus		180 days
Secondary	Postprandial Insulin (PPI) Levels Change in Patients with Type 2 Diabetes Mellitus		180 days