The aim of this study is the evaluation of effect of BCG vaccination in treatment of patients with type 1 diabetes mellitus. Fifty- two patients with type 1 diabetes mellitus will enrolled who treated with insulin for ≥ 10 years. The place of study will be clinic of diabetes in Ali-asghar Hospital affiliated to Shiraz University of Medical Sciences. A questionnaire including age, sex, duration of disease, amount of daily insulin and so on will record by a physician. The patients with duration of insulin therapy more than 10 years, negative HIV, negative tuberculin test, HbA1C lower than 8% will participate in this study. The patients will be randomized to two groups: interventional and control group.
In interventional group, the patients will take BCG vaccination 0.2 cc intradermal in deltoid muscle in baseline, 4 weeks later, 1 year after the first dose. In control group will be the same except normal saline instead BCG.
Measuring fasting blood sugar, C-peptide, HbA1C will be done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042919940N2
Registration date:2017-05-29, 1396/03/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-05-29, 1396/03/08
Registrant information
Name
Mozhgan Moghtaderi
Name of organization / entity
Allergy Research Center- Shiraz University of Medical Sciences, Shiraz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 71 3630 2587
Email address
moghtadery@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice- chancellor for research, Shiraz University of Medical Sciences, Sayed Basir Hashemi
Grant number is 95-01-106-11565
Expected recruitment start date
2017-06-01, 1396/03/11
Expected recruitment end date
2018-06-01, 1397/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of BCG vaccination in treatment of patients with type 1 diabetes mellitus
Public title
The effect of BCG vaccination in treatment of patients with type 1 diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: patients with type 1 diabetes mellitus
Duration of insulin injection at least for 10 years
Age 18 to 55 years
negative HIV antibody
Hb A1C < 8%
negative tuberculin test
Exclusion criteria: pregnancy
Having tuberculosis infection recent or before
Using immunosuppressive medications
Hb A1C > 8%
Using high dose of aspirin( > 160 mg per day)
Having HIV infection
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be based on random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand strret
City
Shiraz
Postal code
Approval date
2016-10-01, 1395/07/10
Ethics committee reference number
IR.SUMS.REC.1395.109-11565
Health conditions studied
1
Description of health condition studied
Endocrine disease
ICD-10 code
E10-E14
ICD-10 code description
E10-E14
Primary outcomes
1
Description
fasting blood sugar
Timepoint
0-1-3-4-8-12-16-20-24-28-32-36-40-44-48-52 weeks after intervention
Method of measurement
Glucometer
Secondary outcomes
1
Description
HbA1C
Timepoint
0-4 -8- 12- 20- 32- 44-52 weeks after starting the study
Method of measurement
Enzymatic method
Intervention groups
1
Description
In interventional group, the patients will take BCG vaccination 0.2 cc intradermal in deltoid muscle in baseline, 4 weeks later, 1 year after the first dose.
Category
Treatment - Drugs
2
Description
In control group, the patients will take normal saline 0.2 cc intradermal in deltoid muscle in baseline, 4 weeks later, 1 year after the first dose.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali- Asghar Allergy Clinic
Full name of responsible person
Mozhgan Moghtaderi
Street address
Meshkinfam Avenue
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Zand strret
City
Shiraz
Grant name
95-01-106-11565
Grant code / Reference number
95-01-106-11565
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Behzad Shakerian
Position
Allergist
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
00
Fax
Email
behzad5tyahoo.com@
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Moghtaderi
Full name of responsible person
Mozhgan
Position
Allergist
Other areas of specialty/work
Street address
Zand strret
City
Shiraz
Postal code
Phone
+98 71 3832 1385
Fax
Email
moghtadery@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Allergy Research Center
Full name of responsible person
Shirin Frajadian
Position
Professor of Immunology
Other areas of specialty/work
Street address
Zand strret
City
Shiraz
Postal code
Phone
+98 71 3626 8771
Fax
Email
farjads@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)