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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 2
- 主要终点
- Сhanged glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects with diabetes mellitus type 2 with confirmed levels of glycated hemoglobin (HbA1c) ≥ 6.5%
排除标准
- •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;
研究组 & 干预措施
placebo group
干预措施: placebo comparator (Other)
enhanced L-gluthathione group
干预措施: enhanced glutathione (Dietary Supplement)
结局指标
主要结局
Сhanged glutathione (GSH) levels in erythrocyte hemolysate change in patients with type 2 diabetes mellitus
时间窗: 180 days
次要结局
- 8-Oxoguanine (8-OHdG) Levels Change in Patients with Type 2 Diabetes Mellitus(180 days)
- Glycated Hemoglobin Concentration (HbA1c) Change in Patients with Type 2 Diabetes Mellitus(180 days)
- Postprandial Insulin (PPI) Levels Change in Patients with Type 2 Diabetes Mellitus(180 days)
- Oxidized Glutathione (GSSG) 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)
- 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)