Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease
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Protocol summary
Among patients with type 2 diabetes and coronary heart disease referred to Cardiology 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.
Among patients with type 2 diabetes and coronary heart disease referred to Naghavi Cardiology 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.
Among patients with type 2 diabetes and coronary heart disease referred to Naghavi Cardiology 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.
از بین بیماران دیابتی تیپ 2 با بیماری کرونر قلبی ارجاع شده به کلینیک قلب 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.
از بین بیماران دیابتی تیپ 2 با بیماری کرونر قلبی ارجاع شده به کلینیک قلب 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.
از بین بیماران دیابتی تیپ 2 با بیماری کرونر قلبی ارجاع شده به کلینیک قلب 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.
General information
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correction
correction
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تصحیح
تصحیح
Subjects aged 45-85 years
Patients diagnosed with type 2 diabetes and coronary heart disease
Subjects aged 40-85 years
Patients diagnosed with type 2 diabetes and coronary heart disease
Subjects aged 4540-85 years Patients diagnosed with type 2 diabetes and coronary heart disease
معیارهای ورود مطالعه: افراد 85-45 ساله
بیماران مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی.
معیارهای ورود مطالعه: افراد 85-40 ساله
بیماران مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی.
معیارهای ورود مطالعه: افراد 85-4540 ساله بیماران مبتلا به بیماری دیابت تیپ 2 و کرونر قلبی.
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of probiotic 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 probiotic supplement (n=30) or placebo (n=30).
Settings and conduct
Among patients with type 2 diabetes and coronary heart disease referred to Naghavi Cardiology 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.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with type 2 diabetes and coronary heart disease aged 40 to 85 years. Exclusion criteria: Consuming probiotic and/or synbiotic within three months prior to the intervention, taking prebiotic, antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids, taking antibiotics, having an acute myocardial infarction and a cardiac surgery in the past three months, renal or hepatic failure.
Intervention groups
Intervention group: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 12 weeks orally. Control group: Placebo capsule (Barij essence, Kashan, Iran), daily, for 12 weeks orally.
Main outcome variables
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
correction
Acronym
IRCT registration information
IRCT registration number:IRCT2017082733941N5
Registration date:2017-09-07, 1396/06/16
Registration timing:retrospective
Last update:2019-10-11, 1398/07/19
Update count:3
Registration date
2017-09-07, 1396/06/16
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
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-08-17, 1396/05/26
Expected recruitment end date
2017-09-02, 1396/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease
Public title
Effect of probiotic supplementation in treatment of coronary heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects aged 40-85 years
Patients diagnosed with type 2 diabetes and coronary heart disease
Exclusion criteria:
Consuming probiotic and/or synbiotic within three months prior to the intervention
Taking prebiotic, antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids
Taking antibiotics
Having an acute myocardial infarction and a cardiac surgery in the past three months
Renal or hepatic failure
Age
From 40 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
2017-08-16, 1396/05/25
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.37
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.9
ICD-10 code description
Chronic ischaemic heart disease, unspecified
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
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
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Total cholesterol
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
Systolic blood pressure
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Manometer
10
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: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule (Tak Gen Zist Pharmaceutical Company, Tehran, Iran), daily, for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi cardiology 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 5546 3378
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
Ph.D of Nutrition
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
Ph.D of Nutrition
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
Ph.D of Nutrition
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