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

Benha University90 enrolled

Overview

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).

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: 1. full neurological evaluation including motor, sensory, ankle reflex, Tests for cardiac parasympathetic action 2. nerve conduction study 3. neuromuscular ultrasound 4. HbA1C 5- HDL-C\& LDL-C

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Polyneuropathy Diabetes Mellitus, Type 2

Interventions

Alpha lipoic acidDRUG

Participants will be prescribed 600 mg/day ALA (thiotacid) orally, for 3 months, and will be advised not to discontinue this medication

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Benha University Hospital

Banhā, Qalyubia Governorate, Egypt

Outcomes

Primary Outcomes

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)

Time frame: : 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).