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CompletedNCT04097691Updated May 7, 2020

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

An observational study in Painful Diabetic Neuropathy, sponsored by Ministry of Health and Population, Egypt. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-05-07.

Sponsored by Ministry of Health and Population, Egypt · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 50 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Painful Diabetic Neuropathy

Keywords

  • diabetes mellitus
  • diabetic neuropathy
  • pain
  • glucose 10%
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 260 observational studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Ministry of Health and Population, Egypt is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patient has conditions that could affect the evaluation of painful DPN, or non-diabetic neurologic disorders.
  2. Patient has skin conditions in the area affected by the neuropathy that could alter sensation.
  3. Patient with history of drug abuse.
  4. patients on any drug for diabetic neuropathy like pregabalin or gabapentin. No side effects were monitored during the period of treatment.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • on subcutaneous glucose

    this 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.

    Drug: GLUCOSE 10%

  • control(not receiving treatment)

    the second group is considered as control.received no treatment.

    Drug: GLUCOSE 10%

Interventions

  • DrugGLUCOSE 10%

    subcutaneous glucose 0.5 ml per site around subcutaneous nerves

    Also known as: dextrose 10%

06

What researchers measure

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)

    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.

    Time frame: from baseline to 2 months

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

    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.

    Time frame: from baseline to 2 months

07

Study locations

1 site
  • Mahmoud Younis
    Cairo, 11759, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04097691
Lead sponsor
Ministry of Health and Population, Egypt
Responsible party
mahmoud younis (Principal Investigator, Ministry of Health and Population, Egypt) — Principal investigator
First posted
Sep 20, 2019
Start date
Jul 14, 2019
Primary completion
Oct 9, 2019
Completion
Oct 9, 2019
Last update
May 7, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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