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

NCT ID: NCT04322240

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-02

Study Completion Date

2020-12-23

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:

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

Conditions

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Diabetic Polyneuropathy Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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type 2 DM with peripheral neuropathy

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.

Group Type EXPERIMENTAL

Alpha lipoic acid

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Thiotacid

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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Waleed Ahmed Salaheldeen Hassan

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amira Mohamady, MD

Role: PRINCIPAL_INVESTIGATOR

Benha university- Qaluibya- Egypt

Locations

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Benha University Hospital

Banhā, Qalyubia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Benha22020

Identifier Type: -

Identifier Source: org_study_id