Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy and Different Metabolic Parameters

Conditions
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Diabetic Polyneuropathy, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Alpha lipoic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient's agreement to participate Diabetic peripheral neuropathy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: type 2 DM with peripheral neuropathy<br>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. | Drug: Alpha lipoic acid<br>* Participants will be prescribed 600 mg/day ALA (thiotacid) orally, for 3 months, and will be advised not to discontinue this medication<br>* Other names: Thiotacid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monofilament test of both feet | 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) | : through study completion, an average of 3months | 
| Vibration Perception Threshold (VPT) | 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). | : through study completion, an average of 3 months | 
| neuromuscular ultrasound | the cross sectional area of the posterior tibial nerve will be assessed in both sides at baseline and after use of alpha lipoic acid | : through study completion, an average of 3 months | 
| concentration of Hemoglobin A1c | the participants were divided into two categories that include good glycemic control (HA1c≤7%), poor glycemic control (≥ HA1c 7 %), | : through study completion, an average of 3 months | 
| serum concentrations of high density lipoproteins-cholesterol (HDL-C) | 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 | : through study completion, an average of 3 months | 
| serum concentrations of low density lipoproteins-cholesterol (LDL-C) | a patient of LDL-C equal or more than 3.3mmol/L (129mg/dl) is defined as dyslipidemic. | : through study completion, an average of 3 months | 
| ankle reflex | ranging from 0 (absent) to 4 (hyperactive with clonus) | : through study completion, an average of 3 months | 
| Measurement of nerve conduction velocity | 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 | : through study completion, an average of 3 months | 
| measurement of Compound Muscle Action Potential (CMAP) amplitudes | 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 | : through study completion, an average of 3 months | 
| measurement of Compound Muscle Action Potential (CMAP) distal latency | 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 | : through study completion, an average of 3 months |