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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetic Polyneuropathy
• Interventions: Drug: Alpha lipoic acid

• Registration Number: NCT04322240
• Lead Sponsor: Benha University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-26
• Study Start: 2020-04-02
• Primary Completion: 2020-10-23
• Status Verified: 2020-12
• Study Completion: 2020-12-23
• Last Update Submitted: 2020-12-29
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
type 2 DM with peripheral neuropathy	Alpha lipoic acid	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.

Primary Outcome Measures

Name	Time	Method
ankle reflex	: through study completion, an average of 3 months	ranging from 0 (absent) to 4 (hyperactive with clonus)
monofilament test of both feet	: 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	: 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	: 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	: 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
Vibration Perception Threshold (VPT)	: 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	: 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	: 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)	: 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)	: 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.

Trial Locations

Locations (1)

Benha University Hospital; 🇪🇬 Banhā, Qalubiya, Egypt