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IRCT20220920056004N1 IRCT 2022-12-21 Qazvin University of Medical Sciences Determining the relationship between Helicobacter pylori eradication treatment and blood sugar control in type 2 diabetic patients Determining the relationship between Helicobacter pylori eradication treatment and blood sugar control in type 2 diabetic patients 2022-12-31 anticipated 108 Complete https://irct.ir/trial/66598 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Condition 1: Helicobacter pylori. Condition 2: Type 2 diabetes mellitus. Intervention 1: 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). Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Satisfaction of participants
public Taha Rezayian
Bahonar street
Qazvin Iran (Islamic Republic of) 34197-58911 +98 28 3333 6001 taharezaiyan@gmail.com Qazvin University of Medical Sciences scientific Taha Rezaiyan
Bahonar street
Qazvin Iran (Islamic Republic of) 34197-58911 +98 28 3333 6001 taharezaiyan@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) All asymptomatic diabetic patients whose Helicobacter pylori test is positive Informed consent of the patient regarding participation in the study no limit no limit Both 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 B96.81 E11 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Type 2 diabetes mellitus Treatment - Drugs Placebo 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). 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. 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. Qazvin University of Medical Sciences Approved 2022-09-04 Ethics Committee of Qazvin University of Medical Sciences Research and technology deputy, Mavaddat Alley, Shahid Beheshti Blvd, Qazvin , Iran Qazvin Qazvin Iran (Islamic Republic of)