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

NCT04097691 | Completed FDA Drug

• 1 other identifier: mahmoudyounis
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Painful Diabetic Neuropathy

Keywords

diabetes mellitus; diabetic neuropathy; pain; glucose 10%

Outcome Measures

Primary Outcomes (2)

• 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.

  from baseline to 2 months

• 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.

  from baseline to 2 months

Study Arms (2)

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

GLUCOSE 10% DRUG

subcutaneous glucose 0.5 ml per site around subcutaneous nerves

Also known as: dextrose 10%

control(not receiving treatment); on subcutaneous glucose

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Health and Population, Egypt: lead

Study Sites (1)

Mahmoud Younis

Cairo, 11759, Egypt

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 20, 2019
• Study Start: July 14, 2019
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)