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Glycemic and Oxidative Status of Patients with Type 2 Diabetes Mellitus Following Oral Administration of Alphalipoic Acid: A Randomized Double-Blinded Placebo-controlled Study

補充硫辛酸對於第2型糖尿病患的血糖的氧化壓力的影響:隨機雙盲對照研究

摘要


對糖尿病患而言,即使血糖獲得良好控制,仍會由於體內自由基過多而誘發併發症。此次隨機雙盲臨床對照實驗想瞭解補充硫辛酸對於糖尿病患者的血糖和氧化壓力的影響。從門診招募38名第2型糖尿病患者,隨機分配到安慰劑組或試驗組(硫辛酸劑量分別為每日300、600、900、1200mg)。實驗進行6個月。實驗期前後,測量受試者的血糖值和氧化壓力指標。實驗結果顯示隨著硫辛酸服用劑量越高,空腹血糖和糖化血色素有逐漸下降的趨勢。安慰劑組的尿中F2α-IsoP濃度在實驗期後升高,服用硫辛酸者則未增加,表示硫辛酸或許有助於抑制糖尿病患者的脂肪過氧化作用。然而各組尿液中8-OHdG及微白蛋白濃度和血清肌酸酐並無明顯差異。安全性評估方面,受試者除一些輕微副作用外,試驗劑量都在可忍受範圍。整體而言,硫辛酸有利於改善糖尿病患者的血糖值,也對防止氧化傷害稍有效益。

並列摘要


Despite well-controlled blood glucose levels, diabetic complications still inevitably take place via several mechanisms including excessive generation of free radicals in patients who suffer from diabetes mellitus (DM). A randomized double-blind placebo-controlled clinical trial to investigate the effectiveness of oral supplementation of DL-alpha-lipoic acid (ALA) on glycemic and oxidative status in DM patients was conducted. Thirty eight outpatients with type 2 DM were recruited and randomly assigned to either placebo or treatment in various doses of ALA (300, 600, 900, and 1200 mg/day) for 6 months. Following the treatment, all subjects were evaluated for glucose status and oxidative biomarkers. Results showed that fasting blood glucose, HbA1c trended to decrease in a dose-dependent manner. Increase of urinary PGF2α-Isoprostanes (F2α-IsoP) was noted in placebo but not ALA-treated groups, indicating possible suppressing action of ALA on lipid peroxidation in DM subjects. 8- Hydroxy-2'-deoxyguanosine (8-OHdG) levels, however, were similar in both placebo and ALA groups as well as urinary microalbumin and serum creatinine. Safety evaluation was monitored and treatment was found to be well tolerated despite some minor side effects. Results from this study reflected the benefits of ALA in glucose status with slight efficiency on oxidative stress-related deterioration in DM patients.

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