Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy and Different Metabolic Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- monofilament test of both feet
研究概览
简要总结
Patients with type 2 DM who are following will be enrolled into the study. Two visits were scheduled for data collection, physical examination and laboratory testing of the patients: the first prior to initiation of alpha lipoic acid (ALA) administration (baseline visit) and the second at the end of the third month following initiation of ALA (2nd visit).
详细描述
This prospective, Interventional study will be conducted at Benha university hospital for 3 months. Patients with type 2 DM who are following at the outpatient internal medicine & diabetes Clinics in Benha Univeristy Hospital and are eligible to participate, will be enrolled into the study. Inclusion criteria comprise the following(1) patient's agreement to participate; (2) diabetic peripheral neuropathy diagnosis (3) treatment with alpha lipolic acid (ALA), had to be stable for 3 months during the study.
Two visits were scheduled for data collection, physical examination and laboratory testing of the patients: the first prior to initiation of ALA administration (baseline visit) and the second at the end of the third month following initiation of ALA (2nd visit).
evaluation include:
- full neurological evaluation including motor, sensory, ankle reflex, Tests for cardiac parasympathetic action
- nerve conduction study
- neuromuscular ultrasound
- HbA1C 5- HDL-C& LDL-C
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's agreement to participate
- •Diabetic peripheral neuropathy
排除标准
- •Causes of neuropathy other than diabetes
- •Severe renal disease
- •Recent treatment for cancer or haematological malignancies;
- •Presence of foot ulcers;
- •Peripheral arterial disease ;
- •Use of agents in the previous 3 months that could interfere with the interpretation of results, such as opiates, vitamin B compounds or antioxidants;
- •Pregnancy
- •Lactation
研究组 & 干预措施
type 2 DM with peripheral neuropathy
Participants will be prescribed 600 mg/day ALA (thiotacid) orally, for 3 months, and will be advised not to discontinue this medication, antidiabetic drugs, or medications used for managing arterial hypertension or dyslipidaemia during the study.
干预措施: Alpha lipoic acid (Drug)
结局指标
主要结局
monofilament test of both feet
时间窗: : through study completion, an average of 3months
5.07 (10 gram) monofilament will be used to test loss of protective sensation of at 10 sites in each feet at baseline and after use of alpha lipoic acid. the score range from 0 (worst) to 10 (best)
Measurement of nerve conduction velocity
时间窗: : through study completion, an average of 3 months
sensory and motor conduction velocity are measured in meter/second in common peroneal and posterior tibial nerves on both sides at baseline and after use of alpha lipoic acid
measurement of Compound Muscle Action Potential (CMAP) amplitudes
时间窗: : through study completion, an average of 3 months
amplitude is measured in micro or millivolts in common peroneal and posterior tibial nerves on both sides at baseline and after use of alpha lipoic acid
measurement of Compound Muscle Action Potential (CMAP) distal latency
时间窗: : through study completion, an average of 3 months
distal latency measured in milliseconds and evaluated in common peroneal and posterior tibial nerves on both sides at baseline and after use of alpha lipoic acid
ankle reflex
时间窗: : through study completion, an average of 3 months
ranging from 0 (absent) to 4 (hyperactive with clonus)
Vibration Perception Threshold (VPT)
时间窗: : through study completion, an average of 3 months
VPT was evaluated using a 128-Hz tuning fork applied bilaterally at the tip of the great toe. Responses were categorized as abnormal (no perception of vibration),present (examiner perceives vibration \<10sec after patient reported disappearance of vibration perception) ,and reduced (examiner perceives vibration \>10 seconds after patient reported disappearance of vibration perception).
concentration of Hemoglobin A1c
时间窗: : through study completion, an average of 3 months
the participants were divided into two categories that include good glycemic control (HA1c≤7%), poor glycemic control (≥ HA1c 7 %),
neuromuscular ultrasound
时间窗: : through study completion, an average of 3 months
the cross sectional area of the posterior tibial nerve will be assessed in both sides at baseline and after use of alpha lipoic acid
serum concentrations of high density lipoproteins-cholesterol (HDL-C)
时间窗: : through study completion, an average of 3 months
A low HDL cholesterol level was defined as \<1.03 mmol/l( 40 mg/dl) for men and \<1.29mmol/L(50 mg/dl) for women
serum concentrations of low density lipoproteins-cholesterol (LDL-C)
时间窗: : through study completion, an average of 3 months
a patient of LDL-C equal or more than 3.3mmol/L (129mg/dl) is defined as dyslipidemic.
次要结局
未报告次要终点
研究者
Waleed Ahmed Salaheldeen Hassan
Assistant professor
Benha University