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NCT Number: NCT04097691

Injection of Subcutaneous Glucose 10% in Small Shots is Effective in the Treatment of Diabetic Neuropathic Pain

Observational cohort prospective study with the following of 100 patients of type 1 and type 2 diabetes mellitus in 2 groups each group 50 patients, each group 30 males, and 20 females,35 patients with type 2 diabetes and 15 patients type 1 diabetes all have diabetic peripheral neuropathy, the second group is considered as control.

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Key information

About this study

Observational cohort prospective study with the following of 100 patients of type 1 and type 2 diabetes mellitus in 2 groups each group 50 patients, each group 30 males, and 20 females,35 patients with type 2 diabetes and 15 patients type 1 diabetes all have diabetic peripheral neuropathy, the second group is considered as control. the ages of all patients are between 20 and 50 years.

The first group was on subcutaneous glucose 0.5 ml per site around subcutaneous nerves in the foot region both on palm and sole.which is repeated every 2 weeks for 2 months.

Pain severity was evaluated by using the Visual Analogue Scale (VAS) which is a numerical rating scales, with a straight horizontal line of 100 mm. which is directed from the left with severe pain to the right with no pain. 1-3 = mild pain,4-6 = moderate pain,7-10 = severe pain.

The evaluation of neuropathy was done by using the Michigan Neuropathy Screening Instrument (MNSI) after translation to the Arabic language.which consists a 15 self-administered questionnaires and examination lower extremities which comprise inspection and examination of vibratory senses and ankle reflexes. A score which is more than 7 was suggested to be abnormal.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients 20 years to 50 years with type 1 or type 2 diabetes who have symptoms of symmetrical peripheral neuropathic pain.
  • female Patients are not pregnant.
  • Patient has a pain score of at least 5 on the Visual Analogue Scale (VAS).
  • Patients are on their antidiabetes medication.
  • patents are not on any medication for peripheral neuropathy.
  • Patient must be able to complete questions on the Michigan Neuropathy Screening Instrument (MNSI).

Exclusion criteria

  • Patient has conditions that could affect the evaluation of painful DPN, or non-diabetic neurologic disorders.
  • Patient has skin conditions in the area affected by the neuropathy that could alter sensation.
  • Patient with history of drug abuse.
  • patients on any drug for diabetic neuropathy like pregabalin or gabapentin. No side effects were monitored during the period of treatment.

Treatment and study plan

GLUCOSE 10%

Drug

subcutaneous glucose 0.5 ml per site around subcutaneous nerves

Other names: dextrose 10%

Primary outcomes

  1. Injection of subcutaneous glucose 10% in small shots is effective in treatment of diabetic neuropathic pain measured the Visual Analogue Scale (VAS)

    Time frame: from baseline to 2 months

    Pain severity was evaluated by using the Visual Analogue Scale (VAS) which is a numerical rating scale, with a straight horizontal line of 100 mm. which is directed from the left with severe pain to the right with no pain. 1-3 = mild pain,4-6 = moderate pain,7-10 = severe pain.

  2. Injection of subcutaneous glucose 10% in small shots is effective in improving neuropathic signs using the Michigan Neuropathy Screening Instrument (MNSI)

    Time frame: from baseline to 2 months

    The evaluation of neuropathy was done by using the Michigan Neuropathy Screening Instrument (MNSI) after translation to the Arabic language. Which consists a 15 self-administered questionnaires and examination of lower extremities which comprise inspection and examination of vibratory senses and ankle reflexes. A score which is more than 7 was suggested to be abnormal.

Sponsors and collaborators

Lead sponsor

Ministry of Health and Population, Egypt

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 20, 2019
Registry last updated
May 7, 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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