Determining the relationship between eradication of h.pylori infection and
blood sugar control in type 2 diabetic patients
Design
The clinical trial has a control group, three-blind, randomized,on 108 patients, sampling is done by the available method. Then they are divided into two groups by Balanced Block Randomization method.
Settings and conduct
Diabetic patients referred to Velayat Hospital with positive H.pylori test are divided into intervention and control groups by Balanced Block Randomization.The blocks are randomly arranged as AABB, BBAA, ABBA, BAAB, ABAB, BABA in the number of 54 blocks.Group A will be treated and group B will be the control. The level of HbA1c and FBS before starting the treatment of H.pylori infection and after proving its eradication by determining the antigen of H.pylori in feces by PCR method, measuring HbA1c again 3 months after the start of treatment. and the difference between HbA1c and FBS before and after treatment is compared.
In the control group, the levels of HbA1c and FBS are measured in stages 1 and 2. During this period, they do not receive Helicobacter eradication therapy.
the patients,the attending physician and the analyst do not know how to choose the patients,the study is triple blind
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All asymptomatic diabetic patients with a positive Helicobacter pylori test
Exit criteria:
People with kidney failure,anemia and hemoglobinopathy
History of antibiotic use in the past one month and proton pump inhibition in the past two weeks
Helicobacter infection treatment history
HbA1C greater than 10
Diabetic patients needing insulin treatment
Intervention groups
Intervention group: patients treated with a four-drug anti-H.pylori regimen of bismuth+metronidazole+amoxicillin+omeprazole for 2 weeks.
Control group: patients receiving placebo
Main outcome variables
Determination of blood sugar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220920056004N1
Registration date:2022-12-21, 1401/09/30
Registration timing:prospective
Last update:2022-12-21, 1401/09/30
Update count:0
Registration date
2022-12-21, 1401/09/30
Registrant information
Name
Taha Rezaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 3285
Email address
taharezaiyan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-31, 1401/10/10
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the relationship between Helicobacter pylori eradication treatment and blood sugar control in type 2 diabetic patients
Public title
Determining the relationship between Helicobacter pylori eradication treatment and blood sugar control in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All asymptomatic diabetic patients whose Helicobacter pylori test is positive
Informed consent of the patient regarding participation in the study
Exclusion criteria:
People with kidney failure, anemia and hemoglobinopathy
History of antibiotic use in the last one month and proton pump inhibitor in the last two weeks
Patients who had a history of treatment for Helicobacter infection in the past
Patients who have hb a1c more than 10
Diabetic patients needing insulin treatment
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
This study is conducted as a Randomized Clinical Trial on all diabetic patients who visited Qazvin Provincial Hospital during the years 1402-1401. Diabetic patients in whom Helicobacter pylori infection was proven were divided into two groups by the Balanced Block Randomization method. Intervention and control will be divided. The blocks will be randomly arranged in the form of AABB, BBAA, ABBA, BAAB, ABAB, BABA in the number of 54 blocks. Group A will be treated and group B will be the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering that the patients do not know in which group they will be placed and that the attending physician will select the control and intervention groups based on random allocation and the person who performs the statistical analysis does not know how to select the patients, the study is a blinded study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Research and technology deputy, Mavaddat Alley, Shahid Beheshti Blvd, Qazvin , Iran
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2022-09-04, 1401/06/13
Ethics committee reference number
IR.QUMS.REC.1401.166
Health conditions studied
1
Description of health condition studied
Helicobacter pylori
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
2
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Determination of blood sugar
Timepoint
The level of HbA1c and FBS before starting the treatment of Helicobacter pylori infection and after proving its eradication with the determination of Helicobacter pylori antigen in stool by PCR method, HbA1c is measured again three months after the start of treatment and the difference between HbA1c and FBS before and after treatment is compared
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will be treated with a four-drug anti-Helicobacter pylori regimen of bismuth + metronidazole + amoxicillin + omeprazole for 2 weeks. Diagnosing diabetes is based on serum sugar equal to or above 126 (14) HbA1c is measured by ELISA method (Diaplus Company) and FBS by glucose oxidase method (Man Company).
Category
Treatment - Drugs
2
Description
Control group: In the control group, HbA1c and fasting blood sugar (FBS) are measured in two stages 1 and 2. During this period, they do not receive the Helicobacter eradication regimen.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Taha Rezaiyan
Street address
Velayat hospital, 22 Bahman Blvd., Minoodar Town
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0620
Email
m.nazarinia99@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Mehdi Mirhashemi
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
medicine@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Taha Rezayian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
taharezaiyan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Taha Rezaiyan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
taharezaiyan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Taha rezaiyan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Bahonar Street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
taharezaiyan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available