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

NCT ID: NCT04097691

Last Updated: 2020-05-07

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

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-14

Study Completion Date

2019-10-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Painful Diabetic Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

GLUCOSE 10%

Intervention Type DRUG

subcutaneous glucose 0.5 ml per site around subcutaneous nerves

control(not receiving treatment)

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

GLUCOSE 10%

Intervention Type DRUG

subcutaneous glucose 0.5 ml per site around subcutaneous nerves

Interventions

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GLUCOSE 10%

subcutaneous glucose 0.5 ml per site around subcutaneous nerves

Intervention Type DRUG

Other Intervention Names

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dextrose 10%

Eligibility Criteria

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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

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health and Population, Egypt

OTHER_GOV

Sponsor Role lead

Responsible Party

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mahmoud younis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mahmoud Younis

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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mahmoudyounis

Identifier Type: -

Identifier Source: org_study_id

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