Oral α-Amylase Enzyme Replacement for the Treatment of Diabetic Polyneuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Sensory Nerve Conduction Velocity (SCV)
研究概览
简要总结
This double-blind, placebo-controlled study evaluated the efficacy of oral α-amylase enzyme replacement therapy in treating early-stage diabetic polyneuropathy (DPN). The study was conducted at Al-Azhar University Hospitals with 83 diabetic patients randomized to receive either fermented deglycyrrhizinated licorice extract (FDGL) containing α-amylase enzyme (2500 IU/gm) or placebo for 6 months. Primary outcomes measured improvements in nerve conduction velocity and vibration perception threshold.
详细描述
Diabetes mellitus complications continue to develop despite optimal glycemic control with insulin. Recent studies suggest that serum amylase deficiency correlates with the severity of diabetic complications. This study hypothesizes that α-amylase enzyme deficiency represents an enzymatic defect in the cascade between activated insulin receptors and mitochondrial energy liberation, contributing to diabetic complications.
α-amylase is a glycolytic enzyme that undergoes entero-pancreatic circulation and is proposed to be a precursor to key phosphorylating enzymes (glycogen phosphorylase, glucokinase, and hexokinase) essential for glycolysis. Supplementation with α-amylase may restore normal carbohydrate metabolism and prevent diabetic complications.
The study drug is a formulation rich in α-amylase enzyme prepared from fermented deglycyrrhizinated licorice root extract, also containing acid-lipase enzyme and naturally occurring flavonoids. The intervention was administered as 500mg capsules twice daily, one hour before meals, for 6 months alongside regular antidiabetic medications.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of Type 1 or Type 2 diabetes mellitus
- •Age between 15 and 65 years
- •Diabetes duration of 1-5 years
- •Body Mass Index (BMI) < 30 kg/m²
- •HbA1c < 9%
- •Serum creatinine < 2mg/dL
- •Serum α-amylase < 45 IU/L (reference range: 28-100 IU/L)
- •Vibration Perception Threshold (VPT) > 15V
- •Absence of clinical symptoms of diabetic polyneuropathy
排除标准
- •Treatment with medications that might influence nerve function (antiepileptic agents, tricyclic antidepressants, sympathomimetic agents)
- •Presence of myopathies
- •Presence of neuropathies from other causes
- •Presence of malignancies
- •Clinical symptoms of diabetic polyneuropathy
- •Inability to comply with study protocol
研究组 & 干预措施
Fermented Deglycyrrhizinated Licorice
Oral capsules containing 500 mg of fermented deglycyrrhizinated licorice root extract standardized to 2500 IU/gm of α-amylase enzyme and naturally occurring flavonoids and acid-lipase. Administered twice daily (1000 mg/day).
干预措施: Fermented Deglycyrrhizinated Licorice (Drug)
Placebo Comparator
500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily.
干预措施: Non-fermented Deglycyrrhizinated Licorice (Dietary Supplement)
结局指标
主要结局
Sensory Nerve Conduction Velocity (SCV)
时间窗: Baseline, 3 months, 6 months
Measurement of nerve conduction velocity in sural nerve using digital electromyography equipment
次要结局
- Vibration Perception Threshold (VPT)(Baseline, 3 months, 6 months)
- Sensory Nerve Action Potential Amplitude (SNAP)(Baseline, 3 months, 6 months)
- Compound Muscle Action Potential Amplitude (CMAP)(Baseline, 3 months, 6 months)
- Motor Nerve Conduction Velocity (MCV)(Baseline, 3 months, 6 months)
- Serum α-amylase Levels(Baseline, 3 months, 6 months)
研究者
Mahmoud I Mostafa
Lecturer of Clinical Pharmacy, Faculty of Pharmacy
Helwan University