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Study of water pre- load Effect on the levels of Glycemic index, lipid profile and serum Copeptin in Diabetic Patients type

Protocol summary

Study aim
1- Determining the effect of water intake before meals on the BMI,energy and received Macronites in patients with type 2 diabetes before and after intervention compared to the control group 2. Determination of the effect of water intake before meals on the mean glycemic index (blood glucose, serum insulin and insulin resistance, HbA1C),serum copeptin, serum lipid profile in type 2 diabetes patients before and after intervention compared to the control group
Design
A clinical trial with a control group - with parallel, double blind, randomized groups
Settings and conduct
From the bu-ali diabetes clinic in Zahedan, we randomly divided 40 patients into two groups and examined the relevant laboratory data before and after the intervention (water intake recommendation).The patient is not aware of the contents of the intervention. The intervention provided is the same in every respect, and the statistician has no information about the members of the groups for the purpose of blindness.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA: All people with type 2 diabetes have been diagnosed with fixed medication during the intervention, aged between 30-65 years.   ExCLUSION criteria:Breastfeeding, Heart disease, History of heart failure during the past 3 months, MI, Acute / Chronic Liver Diseases other than Fatty Liver, Dyslipidemia (Creatinine> 1.62 mg / dl) Hyperthyroidism, Hyperthyroidism, The use of NSAIDs, insulin therapy, and depression medications.
Intervention groups
In the intervention group, people are asked to take 500 cc of water before the main meal and in the control group it is recommended that they do not consume water before eating (in fact, it does not recommend or emphasize water intake)
Main outcome variables
The outcomes of this study can help improve the condition of diabetics

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180910040986N1
Registration date: 2018-10-04, 1397/07/12
Registration timing: prospective

Last update: 2018-10-04, 1397/07/12
Update count: 0
Registration date
2018-10-04, 1397/07/12
Registrant information
Name
gohar sedaghat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3620 4807
Email address
g.sedaghat@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of water pre- load Effect on the levels of Glycemic index, lipid profile and serum Copeptin in Diabetic Patients type
Public title
The effect of Pre-meal water on the treatment of diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All people with type 2 diabetes have been diagnosed Use of fixed drugs during the intervention
Exclusion criteria:
Lacking and Pregnancy No history of heart disease, history of heart failure during the past 3 months, myocardial infarction, acute / chronic liver disease, but not fatty liver, kidney impairment (Creatinine> 1.62 mg / dl) hyperthyroidism and hypothyroidism Use of NSAIDs treatment with Insulin Use of depressant drugs
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization is based on the spss statistical software based on the records and the sample size of the sample envelope, and then we put the case and control group sheets according to the output of the software in the envelope and we use it for sampling.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is unaware of which of the study groups (it is said that it is not known to the two groups whose tectacide is not based on the general diet) and the statistician is not aware of which group of data is available.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
no 7.,ladan blvd.,beheshti town
City
shiraz
Province
Fars
Postal code
71896-57936
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.ZAUMS.REC.1397.202

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
serum copeptin
Timepoint
Before the intervention and 2 months later
Method of measurement
laboratory kit

Secondary outcomes

1

Description
serum insulin
Timepoint
The beginning and the end of the intervention
Method of measurement
laboratory kit

Intervention groups

1

Description
Intervention group: The group is advised to consume 500 cc water before each meal
Category
Lifestyle

2

Description
Control group: A group that refuses to consume water before eating, and no recommendation is made for water intake
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
bu-ali diabetes clinic
Full name of responsible person
Sedaghat Gohar
Street address
no 8., 7 ladan Blvd., Beheshti town
City
SHIRAZ
Province
Fars
Postal code
7189657936
Phone
+98 71 3620 4807
Email
g.sedaghat@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farzaneh Montazeri Far
Street address
Zahedan University Of Medical Science,.Dr Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 1341 6708
Email
montazery@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Gohar Sedaghat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No.8, ladan7 street,beheshti town
City
Shiraz
Province
Fars
Postal code
7189657936
Phone
+98 71 3620 4807
Fax
Email
g.sedaghat@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Gohar Sedaghat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No.8, ladan7 street,beheshti town
City
Shiraz
Province
Fars
Postal code
7189657936
Phone
+98 71 3620 4807
Fax
Email
g.sedaghat@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Gohar Sedaghat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No.8, ladan7 street,beheshti town
City
Shiraz
Province
Fars
Postal code
7189657936
Phone
+98 71 3620 4807
Fax
Email
g.sedaghat@zaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
The main variables information will be shared
When the data will become available and for how long
Since year 2020
To whom data/document is available
Researchers working in scientific and research centers
Under which criteria data/document could be used
Use of data in other researches may be allowed
From where data/document is obtainable
To receive any kind of information, please contact the author of the project by e-mail "vazheh4@yahoo.com"
What processes are involved for a request to access data/document
After receiving the email, can find the correct documentation after a month.
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