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| Name | Class |
|---|---|
| Center of New Medical Technologies | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enhanced L-gluthathione group | Experimental |
| |
| placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enhanced glutathione | Dietary Supplement | L-glutathione (in combination with tannin, low molecular weight chitosan and polyethylene glycol) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Сhanged glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidized Glutathione (GSSG) Levels Change in Patients with Type 2 Diabetes Mellitus | 180 days | |
| 8-Oxoguanine (8-OHdG) Levels Change in Patients with Type 2 Diabetes Mellitus | 180 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of New Medical Technologies | Novosibirsk | Novosibisk Region | 630090 | Russia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| placebo comparator | Other | placebo group |
|
| Glycated Hemoglobin Concentration (HbA1c) Change in Patients with Type 2 Diabetes Mellitus |
| 180 days |
| Fasting Glucose (FPG) Levels Change in Patients with Type 2 Diabetes Mellitus | 180 days |
| Postprandial Glucose (PPG) Levels Change in Patients with Type 2 Diabetes Mellitus | 180 days |
| Fasting Insulin (FPI) Levels Change in Patients with Type 2 Diabetes Mellitus | 180 days |
| Postprandial Insulin (PPI) Levels Change in Patients with Type 2 Diabetes Mellitus | 180 days |
| D004700 | Endocrine System Diseases |