Protocol summary
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Study aim
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The aim of this study is to determine the effects of carbohydrate versus fat restriction on metabolic profiles among type 2 diabetes patients with coronary heart disease (CHD).
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Design
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
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Settings and conduct
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Population and sample size: 56 type 2 diabetes patients with CHD eligible and referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Overweight patients aged 40-85 years old and diagnosed with type 2 diabetes and coronary heart disease. Exclusion Criteria: Consuming antiobesity medications within the last 3 months, having an acute myocardial infarction and cardiac surgery within the last 3 months, renal or liver failure.
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Intervention groups
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Intervention: Patients will be assigned to receive either carbohydrate restriction (n=28) or fat restriction (n=28). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles. Start and end date of intervention: 8 weeks.
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Main outcome variables
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Outcomes: Biomarkers of insulin metabolism (primary outcomes), and lipid and metabolic profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.
General information
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Reason for update
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Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201601025623N61
Registration date:
2016-01-09, 1394/10/19
Registration timing:
retrospective
Last update:
2019-11-10, 1398/08/19
Update count:
1
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Registration date
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2016-01-09, 1394/10/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2015-11-01, 1394/08/10
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Expected recruitment end date
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2015-11-21, 1394/08/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial of the effect of low-carbohydrate compared with low-fat diet on metabolic profiles in type 2 diabetes patients with coronary heart disease
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Public title
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Effect of diet therapy in treatment of Coronary Heart Disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Overweight patients aged 40-85 years old
Diagnosed with type 2 diabetes and coronary heart disease
Exclusion criteria:
Consuming antiobesity medications within the last 3 months
Having an acute myocardial infarction and cardiac surgery within the last 3 months
Renal or liver failure
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Age
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From 40 years old to 85 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to receive either carbohydrate restriction (n = 28) or fat restriction (n = 28). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-11-01, 1394/08/10
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Ethics committee reference number
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IR.Kaums.REC.1394.96
Health conditions studied
1
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Description of health condition studied
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Coronary Heart Disease
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ICD-10 code
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I25.9
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ICD-10 code description
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Ischaemic heart disease (chronic) NOS
Primary outcomes
1
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Elisa kit
2
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Elisa kit
Secondary outcomes
1
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Description
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hs-CRP
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Elisa kit
2
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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HDL-cholesterol
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
5
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Description
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Total antioxidant
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
6
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
7
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
8
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Description
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VLDL
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
9
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Description
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LDL
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
10
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Description
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FPG
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
11
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
Intervention groups
1
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Description
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Carbohydrates restriction group: 43-47% carbohydrates, 36-40% fats, for 8 weeks.
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Category
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Other
2
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Description
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Fats restriction group: 60-65% carbohydrates, 20-25% fats, for 8 weeks.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available