The purpose of this study is to investigate the effect of walnut oil on glycemic control and it’s randomized, single-blind and done in single-center.
Inclusion Criteria: Patients with type2 diabetes aged between 20 t0 80 years with at least 2 years past their diagnosis and receiving maximum 2 anti-diabetic drugs.
Exclusion Criteria: Patients who have a history of chronic or metabolic diseases known to affect blood suger or Diabetic Patients who have taken insulin.
The sample size is 100 patients are divided into two groups: intervention group and control. intervention group will received 15 gr walnut oil daily for 3 months and the control group hasn’t received any intervention.
Before and after the intervention, FBS, HbA1c and weight have been checked; and then the statistical studies have been performed on the data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014022216682N1
Registration date:2014-03-19, 1392/12/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-19, 1392/12/28
Registrant information
Name
Kamran Aqasadeghi
Name of organization / entity
Shiraz University of Medical Sience
Country
Iran (Islamic Republic of)
Phone
+98 71 1612 5609
Email address
hakimih@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-03-01, 1392/12/10
Expected recruitment end date
2014-03-16, 1392/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of walnut oil on glycemic control in type 2 diabetic patients referring to Shiraz Healthy Heart Home
Public title
Effects of walnut oil on glycemic control in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with diabetes age 20 and maximum age 80; with at least 2 years past their diagnosis; Patients with diabetes who are receiving maximum 2 anti-diabetic drug.
Exclusion Criteria: Patients who have a history of chronic or metabolic diseases known to affect blood suger; Diabetic Patients who take insulin.
Age
From 20 years old to 80 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
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Postal code
7134814336
Approval date
2013-06-17, 1392/03/27
Ethics committee reference number
CT-P-92-5670
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
HbA1C
Timepoint
Before the experiment, three months after the intervention.
Method of measurement
biochemical measurements on blood sample
2
Description
FBS
Timepoint
Before the experiment, three months after the intervention.
Method of measurement
biochemical measurements on blood sample
Secondary outcomes
1
Description
Weight
Timepoint
Before the experiment, three months after the intervention.
Method of measurement
Electronic Scales
Intervention groups
1
Description
Control group : no intervention
Category
Treatment - Drugs
2
Description
. Intervention group:use walnut oil orally 15 grams per day for90 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiovascular Research Center of Shiraz University of Medical Sciences
Full name of responsible person
Hossein Hakimi
Street address
Cardiovascular Research Center, Shahid Faghihi Hospital, Zand Blvd, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Midical Sciences
Full name of responsible person
Mrs Hoghooghi
Street address
Cardiovascular Research center, Shahid Faghihi Hospital, Zand Blvd, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Midical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kamran AQasadqy
Position
Associate Professor of Cardiology
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Postal code
7134844119
Phone
+98 71 1234 3529
Fax
+98 71 1234 3529
Email
hakimih@sums.ac.ir hakimihosein64@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kamran AQasadqy
Position
Associate Professor of Cardiology
Other areas of specialty/work
Street address
Cardiovascular Research center,Shahid Faghihi Hospital,Zand Blvd, Shiraz
City
Shiraz
Postal code
7134844119
Phone
+98 71 1234 3529
Fax
+98 71 1234 3529
Email
hakimih@sums.ac.irhakimihosein64@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hossein Hakimi
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Postal code
7134844119
Phone
+98 71 1612 5609
Fax
+98 71 1234 3529
Email
hakimihosein64@yahoo.com hakimih@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)