protocolSection identificationModule nctId: NCT06313164, orgStudyIdInfo id: SW009, briefTitle: The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin (HbA1c) Levels in Type 2 Diabetes Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-20, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: S.LAB (SOLOWAYS), class: OTHER, collaborators name: Center of New Medical Technologies, descriptionModule briefSummary: 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., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 217, type: ACTUAL, armsInterventionsModule interventions name: enhanced glutathione, interventions name: placebo comparator, outcomesModule primaryOutcomes measure: Reduced glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus, secondaryOutcomes measure: Oxidized Glutathione (GSSG) Levels Change in Patients with Type 2 Diabetes Mellitus, secondaryOutcomes measure: 8-Oxoguanine (8-OHdG) Levels Change in Patients with Type 2 Diabetes Mellitus, secondaryOutcomes measure: Glycated Hemoglobin Concentration (HbA1c) Change in Patients with Type 2 Diabetes Mellitus, secondaryOutcomes measure: Fasting Glucose (FPG) Levels Change in Patients with Type 2 Diabetes Mellitus, secondaryOutcomes measure: Postprandial Glucose (PPG) Levels Change in Patients with Type 2 Diabetes Mellitus, secondaryOutcomes measure: Fasting Insulin (FPI) Levels Change in Patients with Type 2 Diabetes Mellitus, secondaryOutcomes measure: Postprandial Insulin (PPI) Levels Change in Patients with Type 2 Diabetes Mellitus, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center of New Medical Technologies, city: Novosibirsk, state: Novosibisk Region, zip: 630090, country: Russian Federation, geoPoint lat: 55.0415, lon: 82.9346, hasResults: False