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The effect of medical nutrition therapy on nutrient intake and glycaemic control in diabetic inpatients

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History
# Registration date Revision Id
2 2018-06-08, 1397/03/18 63220
1 2017-12-25, 1396/10/04 30721
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  • General information

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  • Primary outcomes

    #1
    From beginning of the intervention 4 times a day for 7 days ( end of study)
    From beginning of the intervention 4 times a day for 4 days ( end of study)
    از زمان شروع مطالعه 4 بار در روز به مدت 7 روز ( پایان مداخله)
    از زمان شروع مطالعه 4 بار در روز به مدت 4 روز ( پایان مداخله)
    #2
    From beginning of the intervention 4 times a day for 7 days ( end of study)
    From beginning of the intervention 4 times a day for 4 days ( end of study)
    از زمان شروع مطالعه 4 بار در روز به مدت 7 روز ( پایان مداخله)
    از زمان شروع مطالعه 4 بار در روز به مدت 4 روز ( پایان مداخله)
    #3
    From beginning of the intervention 4 times a day for 7 days ( end of study)
    From beginning of the intervention 4 times a day for 4 days ( end of study)
    از زمان شروع مطالعه 4 بار در روز به مدت 7 روز ( پایان مداخله)
    از زمان شروع مطالعه 4 بار در روز به مدت 4 روز ( پایان مداخله)

  • Secondary outcomes

    #1
    From beginning of the intervention and daily for 7 (end of intervention)
    From beginning of the intervention and daily for 4 (end of intervention)
    از شروع مداخله و روزانه به مدت 7 ( پایان مداخله)
    از شروع مداخله و روزانه به مدت 4 ( پایان مداخله)
    7 days food record
    4 days food record
    ثبت غذای 7 روزه
    ثبت غذای 4 روزه
    #2
    From beginning of the intervention and daily for 7 (end of intervention)
    From beginning of the intervention and daily for 4 (end of intervention)
    از شروع مداخله و روزانه به مدت 7 ( پایان مداخله)
    از شروع مداخله و روزانه به مدت 4 ( پایان مداخله)
    7 days food record
    4 days food record
    ثبت غذای 7 روزه
    ثبت غذای 4 روزه
    #3
    From beginning of the intervention and daily for 7 (end of intervention)
    From beginning of the intervention and daily for 4 (end of intervention)
    از شروع مداخله و روزانه به مدت 7 ( پایان مداخله)
    از شروع مداخله و روزانه به مدت 4 ( پایان مداخله)
    7 days food record
    4 days food record
    ثبت غذای 7 روزه
    ثبت غذای 4 روزه
    #4
    Body weight
    empty
    وزن بدن
    empty
    At Beginning of the study ( Before intervention) and day 7 after intervention
    empty
    در ابتدای مطالعه (قبل از شروع مداخله ) و روز 7 پس از شروع مداخله
    empty
    Scale
    empty
    ترازو
    empty
    #5
    Body mass index
    empty
    شاخص توده بدنی
    empty
    At Beginning of the study ( Before intervention) and day 7 after intervention
    empty
    در ابتدای مطالعه (قبل از شروع مداخله ) و روز 7 پس از شروع مداخله
    empty
    Scale and meter
    empty
    ترازو و متر
    empty

  • Intervention groups

    #1
    Intervention group: Participants will received individualized diet and for each participants, during 7 days intervention, four times blood glucose (fasting and two hours after each meal) each day using glucometer and food intake by 7 days food record will measured.
    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.
    گروه مداخله: غذا بر اساس تنظیم رژیم غذایی بصورت فردی ارسال خواهد شد و برای هر بیمار در طول دوره ی مداخله ی 7 روز ه ، در هر روز 4 نوبت قند خون ( ناشتا و دو ساعت بعد از هر وعده غذایی ) با استفاده از گلوکومتر و میزان دریافت غذا از طریق ثبت غذای 7 روزه اندازه گیری خواهد گردید
    گروه مداخله: غذا بر اساس تنظیم رژیم غذایی بصورت فردی ارسال خواهد شد و برای هر بیمار در طول دوره ی مداخله ی 4 روزه ، در هر روز 4 نوبت قند خون ( قبل از هر وعده غذایی و زمان خواب) با استفاده از گلوکومتر و میزان دریافت غذا از طریق ثبت غذای 4 روزه اندازه گیری خواهد گردید
    #2
    Control group:Participants will received routine hospital diabetic diet which is a consistent carbohydrate meal-planning and for each participants, during 7 days intervention, four times blood glucose (fasting and two hours after each meal) each day using glucometer and food intake by 7 days food record will measured.
    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.
    گروه کنترل: غذای دیابتی روتین بیمارستان که براساس میزان ثابت کربوهیدرات در هر وعده می باشد ارسال خواهد شد و برای هر بیمار در طول دوره ی مداخله ی 7 روز ه ، در هر روز 4 نوبت قند خون ( ناشتا و دو ساعت بعد از هر وعده غذایی ) با استفاده از گلوکومتر و میزان دریافت غذا از طریق ثبت غذای 7 روزه اندازه گیری خواهد گردید
    گروه کنترل: غذای دیابتی روتین بیمارستان که براساس میزان ثابت کربوهیدرات در هر وعده می باشد ارسال خواهد شد و برای هر بیمار در طول دوره ی مداخله ی 4روز ه ، در هر روز 4 نوبت قند خون ( قبل از هر وعده غذایی و زمان خواب ) با استفاده از گلوکومتر و میزان دریافت غذا از طریق ثبت غذای 4 روزه اندازه گیری خواهد گردید

Protocol summary

Study aim
The effect of medical nutrition therapy on nutrient intake and glycaemic control in diabetic inpatients
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
inclusion criteria: hospitalized diabetic patients over 18 years, Complete consent form exclusion criteria: ICU patients ; pregnancy and lactation ; tube feeding and parentral feeding patients
Intervention groups
Intervention group will received individualized diet and control group will received routine hospital diabetic diet which is a consistent carbohydrate meal-planning
Main outcome variables
mean blood glucose level mean peak blood glucose level mean nadir blood glucose level

General information

Reason for update
Acronym
IRCT registration information
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
Registration date
2017-12-25, 1396/10/04
Registrant information
Name
Zahra Mousavi Shirazi Fard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1540
Email address
z_mousavi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-29, 1396/10/08
Expected recruitment end date
2018-03-15, 1396/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of medical nutrition therapy on nutrient intake and glycaemic control in diabetic inpatients
Public title
The effect of medical nutrition therapy on diabetic inpatients
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
From 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences , Zand St., Shiraz
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.SUMS.REC.1395.7

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E08-E11
ICD-10 code description
دیابت ملیتوس

Primary outcomes

1

Description
Mean blood glucose level
Timepoint
From beginning of the intervention 4 times a day for 4 days ( end of study)
Method of measurement
Glucometer

2

Description
Mean peak blood glucose level
Timepoint
From beginning of the intervention 4 times a day for 4 days ( end of study)
Method of measurement
Glucometer

3

Description
Mean nadir blood glucose level
Timepoint
From beginning of the intervention 4 times a day for 4 days ( end of study)
Method of measurement
Glucometer

Secondary outcomes

1

Description
Mean calorie intake
Timepoint
From beginning of the intervention and daily for 4 (end of intervention)
Method of measurement
4 days food record

2

Description
Mean carbohydrate intake
Timepoint
From beginning of the intervention and daily for 4 (end of intervention)
Method of measurement
4 days food record

3

Description
Mean protein intake
Timepoint
From beginning of the intervention and daily for 4 (end of intervention)
Method of measurement
4 days food record

Intervention groups

1

Description
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.
Category
Lifestyle

2

Description
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.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Zahra Mousavi Shirazi Fard
Street address
Namazi hospital, , Zand Street
City
Shiraz
Province
Fars
Postal code
11351 – 71937
Phone
+98 71 3628 1540
Email
shirazifard1393@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
7th floor , central building of Shiraz university of medical sciences,Zand st.
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Mazloom
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi st.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71372510015
Email
zohreh.mazloom@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Mazloom
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi st.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71372510015
Email
zohreh.mazloom@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Mousavi Shirazi Fard
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi st.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
shirazifard1393@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the level of blood glucose can be shared confidentially
When the data will become available and for how long
Access period will start 6 months after printing the results
To whom data/document is available
Study data will only be available to researchers working in academic institutions
Under which criteria data/document could be used
Use in meta-analysis
From where data/document is obtainable
Zahra Mousavi Shirazi Fard , 09177017412, shirazifard1393@gmail.com Dr. Zohreh Mazloom, 09171111527,zohreh.mazloom@gmail.com
What processes are involved for a request to access data/document
Providing personal information Providing occupational information Providing information about the reason for requesting data
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