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NCT Number: NCT04322240

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

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).

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Key information

Conditions

Diabetic Polyneuropathy Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital

Banhā, Qalyubia Governorate, 13518, Egypt

About this study

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:

  • full neurological evaluation including motor, sensory, ankle reflex, Tests for cardiac parasympathetic action
  • nerve conduction study
  • neuromuscular ultrasound
  • HbA1C 5- HDL-C& LDL-C

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpha lipoic acid

Drug

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

Other names: Thiotacid

Primary outcomes

  1. monofilament test of both feet

    Time frame: : 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)

  2. Vibration Perception Threshold (VPT)

    Time frame: : 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).

  3. neuromuscular ultrasound

    Time frame: : 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

  4. concentration of Hemoglobin A1c

    Time frame: : 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 %),

  5. serum concentrations of high density lipoproteins-cholesterol (HDL-C)

    Time frame: : 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

  6. serum concentrations of low density lipoproteins-cholesterol (LDL-C)

    Time frame: : 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.

  7. ankle reflex

    Time frame: : through study completion, an average of 3 months

    ranging from 0 (absent) to 4 (hyperactive with clonus)

  8. Measurement of nerve conduction velocity

    Time frame: : 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

  9. measurement of Compound Muscle Action Potential (CMAP) amplitudes

    Time frame: : 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

  10. measurement of Compound Muscle Action Potential (CMAP) distal latency

    Time frame: : 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

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2020
Registry last updated
Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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