The main objectives of this project: proper control of diabetes, type-2 diabetes, weight loss and reduce the need for blood sugar-lowering drugs
Design
In this research, 80 eligible patients referring to Daibet Association were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.To 40 obese patients with type 2 diabetes is characterized. daily 6-4 grams of powder of dried spinach and 5 grams dried okra powder is prescribed for 3 months. to control group (40 patient) on a daily basis spinach and okra not recommended. There twice in the study sample. First introduced at the beginning of the patient and in the second study.
Settings and conduct
To 40 obese patients with type 2 diabetes is characterized. daily 6-4 grams of powder of dried spinach and 5 grams dried okra powder is prescribed for 3 months. to control group (40 patient) on a daily basis spinach and okra not recommended. There twice in the study sample. First introduced at the beginning of the patient and in the second study. Diabetes Research and Clinical Center Kermanshah University of Medical Sciences
Participants/Inclusion and exclusion criteria
Female, being obese and diabetic women with diabetes-2 ---with normal weight and males in this study are not.
Intervention groups
In the intervention group of 40 women on a daily basis spinach and okra and patient drugs according to the instructions provided and to control group (40 patient) on a daily basis spinach and okra not recommended. In the beginning, patients were randomly divided into two groups of 40 people, all sampling done at the beginning of the study and their values will be recorded. After three months administration of a combination of spinach and okra re all samples taken and their results should be analyzed.
Main outcome variables
Loss of appetite, weight loss, reduce the severity of the disease, reducing the need for blood sugar-lowering drugs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171205037760N1
Registration date:2018-01-08, 1396/10/18
Registration timing:registered_while_recruiting
Last update:2018-01-08, 1396/10/18
Update count:0
Registration date
2018-01-08, 1396/10/18
Registrant information
Name
ABBAS ABBASI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3424 9909
Email address
arvinabbasi55@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-19, 1396/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The synergic study effect of Spinach and Okra on glucose, gerlin, introstatin and GLP-1 serum levels and the weight in obsess (BMI>27) diabetic women
Public title
Spinach and okra role in lowering blood sugar, weight, glucose and A1c their role in appetite hormone changes in obese women with type-2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabete type-2
Female
Diabete type-2 with BMI>25
Older than 20 years
Exclusion criteria:
Age
From 20 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two groups
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 Kermanshah University of Medical Sciences
Street address
Martyr Beheshti Boulevard Taleghani Hospital in front of Building No. 2 University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715754693
Approval date
2017-11-15, 1396/08/24
Ethics committee reference number
IR.KUMS.1396.429
2
Ethics committee
Name of ethics committee
Street address
City
Postal code
Approval date
2017-11-15, 1396/08/24
Ethics committee reference number
Health conditions studied
1
Description of health condition studied
Diabetes type -2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
The variables that are placed under review are as follows: 1. weight loss 2. The reduced need for blood sugar-lowering drugs (3) changes in appetite hormones
Timepoint
There twice in the study sample. First introduced at the beginning of the patient and in the second study
Method of measurement
To determine the levels of blood sugar, blood lipids and hemoglobin A1C of biochemical kits are used. To determine the amount of Homones appetite (ghrelin Antrostatin and GLP-1) of ELISA kits are used
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: 40 obese patients with type 2 diabetes is characterized. daily 6-4 grams of powder of dried spinach and 5 grams dried okra powder is prescribed for 3 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research and Clinical Training Center, Kermanshah University of Medical Sciences
Full name of responsible person
Dr Mehr Ali Raimi
Street address
Martyr Beheshti Blvd., Taleghani Hospital Research Center, Kermanshah University of Medical Sciences in Diabetes Education
City
Kermanshah
Province
Kermanshah
Postal code
6715754693
Phone
+98 83 1836 2014
Email
mjavadra@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mr Koroush Hamzei
Street address
Boulevard Taleghani Hospital Diabetes Research and Clinical Training Center, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715754693
Phone
+98 83 1836 2014
Email
arvinabbsi55@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Abbas Abbasi
Position
TEACHER
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Boulevard Taleghani Hospital Diabetes Research and Clinical Training Center, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715754693
Phone
+98 83 1836 2014
Email
arvinabbasi55@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Mehr Ali Rahimi
Position
Teacher
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Boulevard Taleghani Hospital Diabetes Research and Clinical Training Center, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715754693
Phone
+98 33 3424 9909
Email
mjavadra@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Abbas Abbasi
Position
Teacher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Boulevard Taleghani Hospital Diabetes Research and Clinical Training Center, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715754693
Phone
+98 33 3424 9909
Email
ARVINABBASI55@GMAIL.COM
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
In order to be transparent in the research process, the total potential data can be shared after being unidentifiable.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
The data obtained from this study is usable by different people.
Under which criteria data/document could be used
There is no limit to the use of the data obtained from this research.
From where data/document is obtainable
The data obtained from this study is available at the various information bulletins.
What processes are involved for a request to access data/document
Given that the data obtained from this study does not have any restrictions on the public domain information, there is no need for any specific request or process.