Protocol summary
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Study aim
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The effect of medical nutrition therapy on nutrient intake and glycaemic control in diabetic inpatients
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Design
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In this research ,100 eligible hospitalized diabetic patients will chosen. Then participants will randomly divided into two control and intervention groups and a code will allocated to each one of them.
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Settings and conduct
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Intervention group will received individualized diet and control group will received routine hospital diabetic diet which is a consistent carbohydrate meal-planning . This research will done in Shiraz Namazi hospital.
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Participants/Inclusion and exclusion criteria
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inclusion criteria: hospitalized diabetic patients over 18 years, Complete consent form
exclusion criteria: ICU patients ; pregnancy and lactation ; tube feeding and parentral feeding patients
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Intervention groups
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Intervention group will received individualized diet and control group will received routine hospital diabetic diet which is a consistent carbohydrate meal-planning
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Main outcome variables
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mean blood glucose level
mean peak blood glucose level
mean nadir blood glucose level
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171217037916N1
Registration date:
2017-12-25, 1396/10/04
Registration timing:
prospective
Last update:
2018-10-15, 1397/07/23
Update count:
1
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Registration date
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2017-12-25, 1396/10/04
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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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Expected recruitment start date
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2017-12-29, 1396/10/08
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Expected recruitment end date
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2018-03-15, 1396/12/24
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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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The effect of medical nutrition therapy on nutrient intake and glycaemic control in diabetic inpatients
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Public title
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The effect of medical nutrition therapy on diabetic inpatients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Hospitalized diabetic patients over 18 years
Complete consent form
Exclusion criteria:
ICU patients
Pregnancy and lactation
Patients with tube feeding and total parenteral feeding
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Age
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From 19 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not 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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2016-04-23, 1395/02/04
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Ethics committee reference number
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IR.SUMS.REC.1395.7
Health conditions studied
1
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Description of health condition studied
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Diabetes
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ICD-10 code
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E08-E11
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ICD-10 code description
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دیابت ملیتوس
Primary outcomes
1
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Description
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Mean blood glucose level
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Timepoint
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From beginning of the intervention 4 times a day for 4 days ( end of study)
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Method of measurement
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Glucometer
2
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Description
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Mean peak blood glucose level
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Timepoint
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From beginning of the intervention 4 times a day for 4 days ( end of study)
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Method of measurement
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Glucometer
3
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Description
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Mean nadir blood glucose level
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Timepoint
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From beginning of the intervention 4 times a day for 4 days ( end of study)
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Method of measurement
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Glucometer
Secondary outcomes
1
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Description
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Mean calorie intake
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Timepoint
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From beginning of the intervention and daily for 4 (end of intervention)
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Method of measurement
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4 days food record
2
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Description
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Mean carbohydrate intake
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Timepoint
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From beginning of the intervention and daily for 4 (end of intervention)
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Method of measurement
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4 days food record
3
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Description
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Mean protein intake
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Timepoint
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From beginning of the intervention and daily for 4 (end of intervention)
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Method of measurement
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4 days food record
Intervention groups
1
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Description
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Intervention group: Participants will received individualized diet and for each participants, during 4 days intervention, four times blood glucose ( before each meal and bedtime) each day using glucometer and food intake by 4 days food record will measured.
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Category
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Lifestyle
2
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Description
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Control group:Participants will received routine hospital diabetic diet which is a consistent carbohydrate meal-planning and for each participants, during 4 days intervention, four times blood glucose (before each meal and bedtime) each day using glucometer and food intake by 4 days food record will measured.
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Category
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Lifestyle
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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Shiraz 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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Yes - There is 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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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information about the level of blood glucose can be shared confidentially
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When the data will become available and for how long
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Access period will start 6 months after printing the results
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To whom data/document is available
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Study data will only be available to researchers working in academic institutions
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Under which criteria data/document could be used
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Use in meta-analysis
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From where data/document is obtainable
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Zahra Mousavi Shirazi Fard , 09177017412, shirazifard1393@gmail.com
Dr. Zohreh Mazloom, 09171111527,zohreh.mazloom@gmail.com
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What processes are involved for a request to access data/document
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Providing personal information
Providing occupational information
Providing information about the reason for requesting data
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Comments
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