Determining the effect of H-pylori infection treatment on reducing insulin resistance and drug dosage in diabetic patients
Design
150 patients with diabetes and Helicobacter infection are first subjected to standard treatment, after the completion of the treatment with breath test/stool antigen, eradication is confirmed. Then patients are referred to an endocrinology specialist. 3 months after proving eradication of infection and without any change in the drug regime controlling diabetes and lifestyle changes, by FPS and hemoglobin A1C and BP and weight are evaluated. Then, effectiveness of infection treatment is evaluated and compared with the level of these parameters before the eradication of the infection.
Settings and conduct
A quasi-clinical trial study that will be conducted in the second half of 2023 on diabetic patients referred to Afzalipur Hospital, endocrinology clinic and endocrinology specialist office.
Participants/Inclusion and exclusion criteria
Entry: age over 18 and under 60 years; definitely suffering from diabetes based on reliable sources
Failure to enter: unwillingness to participate in the study; suffering from hemoglobinopathies
Intervention groups
Patients with diabetes and Helicobacter infection who receive standard treatment, after treatment with breath test/stool antigen, eradication is confirmed. Then patients are referred to an endocrinologist. 3 months after proving the eradication of the infection and without changing the drug regimen controlling diabetes and changing the lifestyle, the patient was tested by FPS and hemoglobin A1C and BP and weight is assessed. Then, the effectiveness of infection treatment is evaluated and compared with the level of these parameters before the eradication of this infection.
Main outcome variables
The effect of H-pylori infection treatment on reducing insulin resistance and drug dosage in diabetic patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230624058567N1
Registration date:2023-06-26, 1402/04/05
Registration timing:prospective
Last update:2023-06-26, 1402/04/05
Update count:0
Registration date
2023-06-26, 1402/04/05
Registrant information
Name
Omid Eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3325 7470
Email address
o.eslami@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-15, 1402/04/24
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Helico bacter pylori treatment on decrease the insulin resistance and dose of insulin in diabetic person in kerman
Public title
The effect of Helico bacter pylori treatment on decrease the insulin resistance and dose of insulin in diabetic person in kerman
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years and under 60 years
Definite diagnosis of diabetes based on reliable sources
Exclusion criteria:
Unwillingness to participate in the study
Hemoglobinopathy
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
146
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 Kerman University of Medical Sciences
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center, Clinical Research Development Unit
City
Kerman
Province
Kerman
Postal code
7616913911
Approval date
2023-01-28, 1401/11/08
Ethics committee reference number
IR.KMU.AH.REC.1401.259
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection, diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Reducing insulin resistance and drug dosage
Timepoint
Three months after proving the eradication of the infection and without changing the drug regimen controlling diabetes and changing the lifestyle, the patient was tested by fasting plasma sugar and hemoglobin A1C in the same primary laboratory before treatment and tests related to the development of metabolic syndrome, including blood pressure and The patient's weight is assessed. Then, the effectiveness of infection treatment is evaluated on these parameters and compared with the level of these parameters before the eradication of this infection.
Method of measurement
Three months after proving the eradication of the infection and without changing the drug regimen controlling diabetes and changing the lifestyle, the patient was tested by fasting plasma sugar and hemoglobin A1C in the same primary laboratory before treatment and tests related to the development of metabolic syndrome, including blood pressure and The patient's weight is assessed. Then, the effectiveness of infection treatment is evaluated on these parameters and compared with the level of these parameters before the eradication of this infection.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients whose diabetes has already been confirmed and the presence of Helicobacter infection in them has been confirmed by fecal antigen tests are first treated with standard treatment, and after the treatment is completed with a breath test or fecal antigen, their eradication is confirmed. . Then the patients are referred to an endocrinology specialist to check their diabetes conditions, and then three months after proving that the infection has been eradicated and without any change in the diabetes control drug regimen and lifestyle changes, the patient is tested by fasting plasma sugar and hemoglobin. A1C is evaluated in the same primary laboratory before treatment and tests related to the development of metabolic syndrome, including blood pressure and patient weight, and then the effectiveness of infection treatment is evaluated on these parameters and compared with the level of these parameters before the eradication of this infection.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Amir Hossein Delkash
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3325 7470
Email
amirdelkash1990@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
a.iranpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Amir Hossein Delkash
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
amirdelkash1990@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amir Hossein Delkash
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
amirdelkash1990@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amir Hossein Delkash
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
amirdelkash1990@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total data
When the data will become available and for how long
Starting six months after the publication of the article
To whom data/document is available
Researchers, students and doctors
Under which criteria data/document could be used
To perform clinical examination
From where data/document is obtainable
General or scientific responsible person
What processes are involved for a request to access data/document