Clinical trial NCT04322240: Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy
Official title: Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy and Different Metabolic Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Polyneuropathy
Diabetes Mellitus, Type 2
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: monofilament test of both feet
timeFrame: : through study completion, an average of 3months
measure: Vibration Perception Threshold (VPT)
timeFrame: : through study completion, an average of 3 months
measure: neuromuscular ultrasound
timeFrame: : through study completion, an average of 3 months
measure: concentration of Hemoglobin A1c
timeFrame: : through study completion, an average of 3 months
measure: serum concentrations of high density lipoproteins-cholesterol (HDL-C)
timeFrame: : through study completion, an average of 3 months
measure: serum concentrations of low density lipoproteins-cholesterol (LDL-C)
timeFrame: : through study completion, an average of 3 months
measure: ankle reflex
timeFrame: : through study completion, an average of 3 months
measure: Measurement of nerve conduction velocity
timeFrame: : through study completion, an average of 3 months
measure: measurement of Compound Muscle Action Potential (CMAP) amplitudes
timeFrame: : through study completion, an average of 3 months
measure: measurement of Compound Muscle Action Potential (CMAP) distal latency
timeFrame: : through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University Hospital
state: Qalubiya
Study officials:
affiliation: Benha university- Qaluibya- Egypt
name: Amira Mohamady, MD
role: PRINCIPAL_INVESTIGATOR
References: