1. Home
  2. Approved trials
  3. » فارسی

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

View the latest revision

History
# Registration date Revision Id
3 2019-10-10, 1398/07/18 109153
2 2019-09-14, 1398/06/23 103576
1 2018-01-18, 1396/10/28 33690
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    Among patients with CHD referred to Naghavi 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.
    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.
    از بین بیماران دیابتی تیپ 2 با بیماری کرونر قلبی ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.
    از بین بیماران دیابتی تیپ 2 با بیماری کرونر قلبی ارجاع شده به کلینیک سرپایی نقوی وابسته به دانشگاه علوم پزشکی کاشان، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.
    Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Unwillingness to cooperate.
    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 .
    معیار ورود به مطالعه: افراد 85-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی. معیار خروج از مطالعه: عدم تمایل به همکاری
    معیار ورود به مطالعه: افراد 85-45 ساله مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی. معیارهای عدم ورود: مصرف سلنیوم، پروبیوتیک و/یا سین بیوتیک سه ماه قبل از مداخله، بیماران مبتلا به اختلالات تیروئید، عدم کارآیی کلیوی شدید و اختلال کبدی، تجربه سکته قلبی حاد و جراحی قلب در سه ماه گذشته.
    Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profile, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
    Outcomes: Insulin resistance (primary outcomes) and other metabolic profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
    پيامدها: مارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
    پيامدها: مقاومت به انسولین (پیامدهای اولیه) و سایر پروفایل متابولیک (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

    Exclusion Criteria: Unwillingness to cooperate.
    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
    معیارهای عدم ورود: عدم تمایل به همکاری.
    معیارهای عدم ورود: مصرف سلنیوم، پروبیوتیک و/یا سین بیوتیک سه ماه قبل از مداخله
    بیماران مبتلا به اختلالات تیروئید
    عدم کارآیی کلیوی شدید و اختلال کبدی
    تجربه سکته قلبی حاد و جراحی قلب در سه ماه گذشته

  • Primary outcomes

    #1
    Insulin
    Insulin resistance
    انسولین
    مقاومت به انسولین
    Elisa kit
    Calculation using HOMA formula
    کیت الایزا
    محاسبه با استفاده از فرمول HOMA
    #2
    Insulin resistance
    empty
    مقاومت به انسولین
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Calculation using HOMA formula
    empty
    محاسبه با استفاده از فرمول HOMA
    empty

  • Secondary outcomes

    #1
    empty
    Insulin
    empty
    انسولین
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Elisa kit
    empty
    کیت الایزا
    #2
    empty
    Beck Depression Inventory
    empty
    پرسشنامه افسردگی بک
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Questionnaire
    empty
    پرسشنامه
    #3
    empty
    Beck Anxiety Inventory
    empty
    پرسشنامه اضطراب بک
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Questionnaire
    empty
    پرسشنامه
    #4
    empty
    Pittsburgh Sleep Quality Index
    empty
    شاخص کیفیت خواب پیتزبرگ
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Questionnaire
    empty
    پرسشنامه
    #5
    empty
    Systolic blood pressure
    empty
    فشار خون سیستول
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Manometer
    empty
    مانومتر
    #6
    empty
    Diastolic blood pressure
    empty
    فشار خون دیاستول
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Manometer
    empty
    مانومتر

  • Recruitment centers

    #1
    Name of recruitment center - English: Naghavi Clinic
    Name of recruitment center - Persian: کلینیک 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 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:

  • Sharing plan

    empty
    Undecided - It is not yet known if there will be a plan to make this available.
    empty
    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست.

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 .
Intervention groups
Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and selenium supplements (Webber Naturals, Coquitlam, Canada), 200 µg, daily, for 12 weeks orally.
Main outcome variables
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
Acronym
IRCT registration information
IRCT registration number: IRCT20170513033941N28
Registration date: 2018-01-18, 1396/10/28
Registration timing: retrospective

Last update: 2019-09-15, 1398/06/24
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
empty
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 (<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.
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
Method of measurement
Manometer

Intervention groups

1

Description
Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and selenium supplements (Webber Naturals, Coquitlam, Canada), 200 µg, daily, for 12 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo (Barij essence, Kashan, Iran), daily, for 12 weeks orally.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Naghavi outpatient Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
asemi_z@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 2999
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

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
Loading...