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
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 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: Unwillingness to cooperate.
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.
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:2018-01-18, 1396/10/28
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: Unwillingness to cooperate.
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
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
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