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

Benha University

Status: Completed

Conditions: Diabetic Polyneuropathy; Diabetes Mellitus, Type 2

Treatments: Drug: Alpha lipoic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04322240

Benha22020

Details and patient eligibility

About

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).

Full description

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

Enrollment: 90 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

type 2 DM with peripheral neuropathy

Experimental group

Description:

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.

Treatment:

Drug: Alpha lipoic acid