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Evaluation the effect of two doses of BCG vaccine on inflammatory factors in the glycemic control on type 1 diabetic patients, a quasi-experimental clinical trial

Protocol summary

Study aim
Determining the effect of BCG vaccine on glycemic control in type 1 diabetic patients and mean levels of HbA1C, FBS, Anti-GAD and Anti ICA, CBC, NBT and Total IgA before and after BCG vaccine injection. Determine the average HbA1C level every three months for one year.
Design
Clinical trial phase 2 to determine efficacy in 16 patients. The sample size was determined by the results of a valid study in SPSS software.
Settings and conduct
After being called to the Diabetes Center, the conditions for the admission of volunteer patients will be examined. Patients with inclusion criteria are referred to the laboratory of Diabetes Center for testing after collecting basic information. At the beginning of the study and one year after treatment, HbA1C, FBS, Anti-GAD, Total IgA, Anti ICA, NBT and CBC tests will be performed. The vaccine will be injected twice. We will not make any intervention or change in the main treatment of patients. Follow-up of patients will continue with HbA1C measurement every three months. It should be noted that patients will be excluded from the study if the second dose is not used.
Participants/Inclusion and exclusion criteria
Patients 6 to 14 years old with type 1 diabetes who have been suffered for at least one year and have received a full dose of insulin.with a Hb A1C level above 7. People without these conditions are not allowed to enter the study.
Intervention groups
HbA1C, FBS, Anti-GAD and Anti ICA, Total IgA, NBT and CBC tests will be performed at the beginning of the study and one year after receiving treatment. The vaccine is given at the same dose for two consecutive months and then patients are followed up every three months by recording HbA1C.
Main outcome variables
HbA1C;FBS;Age;Gender;insulin; Anti-GAD antibody;Anti ICA;Total IgA;CBC NBT

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201012049003N1
Registration date: 2020-10-15, 1399/07/24
Registration timing: prospective

Last update: 2020-10-15, 1399/07/24
Update count: 0
Registration date
2020-10-15, 1399/07/24
Registrant information
Name
Mahtab Ordooei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3728 0228
Email address
dr.ordooei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-16, 1399/07/25
Expected recruitment end date
2020-11-15, 1399/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of two doses of BCG vaccine on inflammatory factors in the glycemic control on type 1 diabetic patients, a quasi-experimental clinical trial
Public title
Effect of BCG in treatment of diabetes type 1
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
HbA1C>7 Get the full dose of insulin having diabetes for at least 1 year (to pass the Honeymoon course) Age category 6 to 14 years
Exclusion criteria:
retinopathy Nephropathy Diabetic neuropathy Macrovascular complications of diabetes HbA1C<7 New cases of type 1 diabetes Having a recurrent infection or a history of allergy to the vaccine at birth Take high doses of corticosteroids History of immunodeficiency disease celiac
Age
From 6 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 16
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of yazd University of Medical Sciences
Street address
Central Administration, Bahonar Sq., Yazd 8916978477 I.R. Iran
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-04-28, 1399/02/09
Ethics committee reference number
IR.SSU.REC.1399.023

Health conditions studied

1

Description of health condition studied
Diabetes type1
ICD-10 code
E10.1
ICD-10 code description
Type 1 diabetes mellitus with ketoacidosis

Primary outcomes

1

Description
HbA1c level in patients
Timepoint
Measurement of HbA1c at the beginning of the study and 3, 6, 9, and 12 months after the first vaccine was given
Method of measurement
blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Diabetes type1 patients, BCG vaccine, two injections at one month intervals
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Mahtab Ordooei
Street address
Yazd Diabetes Research center, Art Hall Alley, Shahid Sadoughi Blvd., Bahonar Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0226
Email
dr.ordooei@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahtab Ordooei
Street address
Yazd Diabetes Research center, Art Hall Alley, Shahid Sadoughi Blvd., Bahonar Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0226
Email
diabet_center@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahtab Ordooie
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Yazd Diabetes Research center, Art Hall Alley, Shahid Sadoughi Blvd., Bahonar Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0226
Email
dr.ordooei@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahtab Ordooei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Yazd Diabetes Research center, Art Hall Alley, Shahid Sadoughi Blvd., Bahonar Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0226
Email
dr.ordooei@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahtab Ordooei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Yazd Diabetes Research center, Art Hall Alley, Shahid Sadoughi Blvd., Bahonar Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0226
Email
dr.ordooei@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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