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Effect of sesame seeds on Fasting Blood Sugar, HbA1C, liver enzymes, cholesterol and triglycerides in patients with type 2 diabetes: A randomized clinical trial

Protocol summary

Study aim
Effect of sesame seeds on Fasting Blood Sugar, HbA1C, liver enzymes, cholesterol and triglycerides in patients with type 2 diabetes
Design
According to the arrival of the subjects in the laboratory, 60 g per day sesame seeds were given to the patients in the case group at 30 g for 2 servings for 2 months and not given to the sesame control group.
Settings and conduct
This research is a randomized clinical trial. The study population included patients with type 2 diabetes who referred to the specialized laboratory of medical school of Rafsanjan University of Medical Sciences in 2015.
Participants/Inclusion and exclusion criteria
Entry requirements: Type 2 diabetes, aged 65-40 years, fasting blood glucose greater than 12 mg / dl and less than 250 mg / dl, serum cholesterol 250-210 mg / dl, triglyceride 200-200 mg / dl, non-intake Blood lipid lowering drugs use glucose lowering drugs such as metformin and glibenclamide when taking glucose lowering drugs. Exit conditions: insulin infusion, history of cardiovascular, liver, kidney, hypothyroidism or hyperthyroidism, high blood pressure, history of insulin treatment, oil or sesame consumption, changes in daily physical activity and diet, pregnancy and lactation, use Oral contraceptives include alcohol, cigarette and drug use history.
Intervention groups
Sesame seeds were prepared in 30g packages. Sesame Consumption: Patients in the case group received 60 grams of sesame seeds per day at 30 grams for 2 months and were not given to the control group. Regarding the fact that the life of the red blood cell is 4 months, the average amount of glycosylated hemoglobin was considered to be 2 months.
Main outcome variables
In general, the benefits of using sesame seeds to reduce the side effects of type 2 diabetes are the aim of this study is to evaluate the effect of sesame seeds on some of the biochemical factors in patients with type 2 diabetes.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190114042359N1
Registration date: 2019-02-27, 1397/12/08
Registration timing: retrospective

Last update: 2019-02-27, 1397/12/08
Update count: 0
Registration date
2019-02-27, 1397/12/08
Registrant information
Name
Atena-Sadat Ghoreishi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4331 5306
Email address
atooo4929@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-05-05, 1394/02/15
Expected recruitment end date
2015-08-11, 1394/05/20
Actual recruitment start date
2015-05-05, 1394/02/15
Actual recruitment end date
2015-08-11, 1394/05/20
Trial completion date
2015-09-16, 1394/06/25
Scientific title
Effect of sesame seeds on Fasting Blood Sugar, HbA1C, liver enzymes, cholesterol and triglycerides in patients with type 2 diabetes: A randomized clinical trial
Public title
Effect of sesame seeds on patients with type 2 diabetes
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Included type 2 diabetes Age 40,65 years Fasting Blood Glucose greater than 12 mg,dl and less than 250 mg,dl Serum cholesterol 210,250 mg,dl Triglyceride 200 mg,dl Non use of lipid lowering drugs Using glucose lowering drugs: metformin and glibenclamide
Exclusion criteria:
Insulin infusion History of cardiovascular, liver, kidney, hypothyroidism or hyperthyroidism High blood pressure History of insulin therapy Oil consumption or sesame seeds Changes in daily physical activity and diet during the course of study Pregnancy and lactation Use of oral contraceptives History of alcohol use, smoking and narcotics
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 72
Randomization (investigator's opinion)
Randomized
Randomization description
The selected individuals are randomly assigned a random numbered table, in which the subjects are divided into two equal groups of 36 (case and control).
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 Rafsanjan University of Medical Sciences
Street address
College of Medical Sciences, University of Medical Sciences, Pistachio Blvd, Gulf Blvd, Rafsanjan.
City
Rafsanjan
Province
Kerman
Postal code
7718175911
Approval date
2015-03-04, 1393/12/13
Ethics committee reference number
31/3757

Health conditions studied

1

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

Primary outcomes

1

Description
Fasting Blood Sugar, HbA1c,cholesterol,triglycerides,Alanine Transaminase, Alkaline Phosphatase
Timepoint
At the beginning of the study (before the intervention) and 2 months after the start of consumption of sesame seeds
Method of measurement
Pathological tests performed on blood samples

Secondary outcomes

1

Description
Fasting Blood Sugar, HbA1C, cholesterol, triglycerides, Alanine Transaminase, Alkaline Phosphatase
Timepoint
At the beginning of the study (before the intervention) and 2 months after the start of consumption of sesame seeds
Method of measurement
Pathological tests performed on blood samples

Intervention groups

1

Description
582/5000Randomly selected. Sesame seeds are purchased from agricultural areas of Yazd and, after confirmation of their species, are put up by botanical experts in packages of 30 grams. In the case group, 60 grams per day of sesame seeds are given in two meals (morning and evening) of 30 grams for 2 months. To weigh 60 g of sesame seeds daily, use two plastic containers in a package and add 30 g of sesame seeds to each of them. In the case group, we will be training daily 2 packets of sesame seeds at 2 o'clock and at the specified hour. After 2 months, all pathological tests are performed again for comparison with the control group.
Category
Treatment - Drugs

2

Description
Control group: They are randomly selected and do not consume any sesame seeds. After 2 months, all pathological tests are performed again for comparison with the intervention group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Laboratory of Rafsanjan college of Medical School
Full name of responsible person
Dr Mahdi Mahmoudi
Street address
College of Medical Sciences, University of Medical Sciences, Pistachio Blvd, Gulf Blvd, Rafsanjan.
City
Rafsanjan
Province
Kerman
Postal code
7718175911
Phone
+98 34 3131 5000
Email
atooo4929@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Mahdi Mahmoudi
Street address
College of Medical Sciences, University of Medical Sciences, Pistachio Blvd, Gulf Blvd, Rafsanjan.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3131 5000
Email
atooo4929@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Atena Sadat Ghoreishi
Position
Faculty of Para-medicine
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Jiroft University of Medical Sciences, Shahed Square, Jiroft.
City
Jiroft
Province
Kerman
Postal code
7861756447
Phone
+98 430315306
Email
atooo4929@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Atena sadat Ghoreishi
Position
Faculty of Para-medicine
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Jiroft University of Medical Sciences, Shahed Square, Jiroft.
City
Jiroft
Province
Kerman
Postal code
7861756447
Phone
+98 34435306
Email
atooo4929@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Atena sadat Ghoreishi
Position
Faculty of Para-medicine
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Jiroft University of Medical Sciences, Shahed Square, Jiroft.
City
Jiroft
Province
Kerman
Postal code
7861756447
Phone
+98 34 4331 5306
Email
atooo4929@yahoo.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
There is a possibility to share some of the data
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
Data will be available to researchers working in academic and academic institutions.
Under which criteria data/document could be used
The data of the questionnaires were analyzed by SPSS software version 0.21. Quantitative data are reported as "± standard deviation" and qualitative data are reported as "number (percent)". In order to compare the mean biochemical changes in the case and control groups, the Independent two-sample t-test will be used.
From where data/document is obtainable
Send the following message to the following email: atooo4929@yahoo.com
What processes are involved for a request to access data/document
From the time the email is sent, requesting information until the request is answered is less than 1 week.
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