Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease
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General information
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تصحیح
تصحیح
At first, all participants were categorized according to age (<65
and ≥65 y) and pre-intervention BMI (25-29.9 and ≥30 kg/m2). Then, patients were randomly allocated into two groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
At first, all participants were categorized according to age and pre-intervention BMI. Then, patients were randomly allocated into two groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
At first, all participants were categorized according to age (<65 and ≥65 y) and pre-intervention BMI (25-29.9 and ≥30 kg/m2). Then, patients were randomly allocated into two groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
در ابتدای مطالعه و بعد از طبقه بندی بر اساس سن (<65 و ≥65) و مقادیر پایه نمایه توده بدنی (29.9-25 و ≥25 کیلوگرم بر متر مربع). سپس، بیماران به طور تصادفی برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه و بعد از طبقه بندی بر اساس سن و مقادیر پایه نمایه توده بدنی. سپس، بیماران به طور تصادفی برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه و بعد از طبقه بندی بر اساس سن (<65 و ≥65) و مقادیر پایه نمایه توده بدنی (29.9-25 و ≥25 کیلوگرم بر متر مربع). سپس، بیماران به طور تصادفی برای دریافت مکمل یاری و پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
Recruitment centers
#1
Name of recruitment center - English: Naghavi outpatient Clinic
Name of recruitment center - Persian: کلینیک سرپایی نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
Name of recruitment center - English: Naghavi outpatient Cardiology Clinic
Name of recruitment center - Persian: کلینیک سرپایی قلب نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
Name of recruitment center - English: Naghavi outpatient Cardiology Clinic Name of recruitment center - Persian: کلینیک سرپایی قلب نقوی Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: Shahid Rajaee Avenue, Kashan Street address - Persian: کاشان، خیابان شهید رجایی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Fax: Email: asemi_z@kaums.ac.ir Web page address:
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of combined probiotic and selenium supplementation on metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD).
Design
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive combined probiotic and selenium supplements (n=30) or placebo (n=30).
Settings and conduct
Among patients with CHD referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Selenium, probiotic and/or synbiotic consumption within the last 3 months, patients with thyroid disorders, severe renal insufficiency and hepatic failure, experiencing an acute myocardial infarction and cardiac surgery within the past 3 months .
Outcomes: Insulin resistance (primary outcomes) and other metabolic profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
correction
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N28
Registration date:2018-01-18, 1396/10/28
Registration timing:retrospective
Last update:2019-10-28, 1398/08/06
Update count:2
Registration date
2018-01-18, 1396/10/28
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-29, 1396/10/08
Expected recruitment end date
2018-01-15, 1396/10/25
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease
Public title
Effect of combined probiotic and selenium supplementation in treatment of coronary heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria: patients diagnosed with type 2 diabetes and coronary heart disease.
Individuals aged 45-85 years.
Exclusion criteria:
Exclusion Criteria: Selenium, probiotic and/or synbiotic consumption within the last 3 months
Patients with thyroid disorders
Severe renal insufficiency and hepatic failure
Experiencing an acute myocardial infarction and cardiac surgery within the past 3 months
Age
From 45 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At first, all participants were categorized according to age and pre-intervention BMI. Then, patients were randomly allocated into two groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2017-12-28, 1396/10/07
Ethics committee reference number
IR.KAUMS.REC.1396.62
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.9
ICD-10 code description
Chronic ischemic heart disease, unspecified
Primary outcomes
1
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
Secondary outcomes
1
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
5
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
10
Description
Beck Depression Inventory
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
11
Description
Beck Anxiety Inventory
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
12
Description
Pittsburgh Sleep Quality Index
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
13
Description
Systolic blood pressure
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Manometer
14
Description
Diastolic blood pressure
Timepoint
At the beginning of the study and after 12 weeks of intervention