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

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ClinicalTrials.gov Identifier: NCT04097691
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
mahmoud younis, Ministry of Health and Population, Egypt

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.

Condition or disease Intervention/treatment
Painful Diabetic Neuropathy Drug: GLUCOSE 10%

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Injection of Subcutaneous Glucose 10% in Small Shots is Effective in the Treatment of Diabetic Neuropathic Pain
Actual Study Start Date : July 14, 2019
Estimated Primary Completion Date : October 9, 2019
Estimated Study Completion Date : October 9, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
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%
subcutaneous glucose 0.5 ml per site around subcutaneous nerves
Other Name: dextrose 10%

control(not receiving treatment)
the second group is considered as control.received no treatment.
Drug: GLUCOSE 10%
subcutaneous glucose 0.5 ml per site around subcutaneous nerves
Other Name: dextrose 10%




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097691


Contacts
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Contact: mahmoud younis, M.Sc 01123944884 ymodmenna@gmail.com

Locations
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Egypt
Mahmoud Younis Recruiting
Cairo, Egypt, 11759
Contact: mahmoud younis, M.Sc medicine    1123944884    ymodmenna@gmail.com   
Contact: mahmoud younis, M.Sc medicine    01123944884    ymodmenna@gmail.com   
Sponsors and Collaborators
Ministry of Health and Population, Egypt

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Responsible Party: mahmoud younis, Principal Investigator, Ministry of Health and Population, Egypt
ClinicalTrials.gov Identifier: NCT04097691     History of Changes
Other Study ID Numbers: mahmoudyounis
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by mahmoud younis, Ministry of Health and Population, Egypt:
diabetes mellitus
diabetic neuropathy
pain
glucose 10%
Additional relevant MeSH terms:
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Neuralgia
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases