This study will assess the effect of curcumin on fructoseamine, lipids profile and lipid peroxidation in type 2 diabetic patients.This study is a clinical trial. Sixty type 2 diabetic patients will randomly categorize into two groups of intervation and control. The intervation group will receive two capsules of 600 mg curcumin and the control group will take placebo daily for 6 weeks.
The blood samples will collect in both groups at the beginning and end of the experiment .The lipid profile will measure by autoanalyzer .The rest of serums will freeze for measuring fructoseamine and malondialdehyde. These tests will repeat after six weeks. Statistical analysis will be done using Spss 15 and paired and independent t tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102045697N2
Registration date:2015-08-01, 1394/05/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-01, 1394/05/10
Registrant information
Name
Nayereh Parsaeyan
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 351820341017
Email address
parsaeyan@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences, Diabetic Center of Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-10-07, 1392/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Curcumin on the Blood Fructoseamine, Lipid profile and Lipid peroxidation in Type 2 Diabetic Patients
Public title
Effect of Curcumin for Treatment of Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria
age 40 to 60, history of diabetes less than 10 years, fasting blood glucose 130 to 200 mg%, 2 hours blood glucose 160 to 250mg%, type of medicine for controlling blood glucose: solphonyl urea and metformin.
Exclusion criteria
people who had surgery, pregnant and lactating women , no change in food habits and physical activity and consumption of medicines which effect on the blood lipids and glucose.
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd Shahid Sadoughi University of Medical Sciences
Street address
Centeral Building of Shahid sadoughi University of Medical Sciences, Bahonar Ring, Yazd
City
Yazd
Postal code
Approval date
2014-08-13, 1393/05/22
Ethics committee reference number
17/1/102061
Health conditions studied
1
Description of health condition studied
diabetes mellitus
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Fructoseamine
Timepoint
before intervation and one and half month after intervation
Method of measurement
micromole per liter
Secondary outcomes
1
Description
Malondialdehyde
Timepoint
before intervation and one and half month after intervation
Method of measurement
nanomole per liter
Intervention groups
1
Description
The intervation group will be 30 type 2 diabetic patients with retinopathy. They will consume two curcumin c power capsules ( 575 mg curcumin c and 25 mg bioperine purchased from Asmi Direct Marketing Pvt.Ltd banglore 560034 India ) daily between their meals for 6 weeks which will be prescribed by doctor.
Category
Treatment - Drugs
2
Description
The control group will be 30 type 2 diabetic patients wihtout retinopathy.They will match in terms of age and sex with case group.They will consume two cellulose capsule (sigma) between their meal for six weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Center of Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Nayereh Parsaeyan
Street address
Diabetes Research Center, Shahid Sadoughi Boulevard, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Diabetes Research Center of Yazd Shahid Sadoughi Univercity of Medical Sciences
Full name of responsible person
Mrs akram barzegary
Street address
Diabetes Research Center of Yazd Shahid Sadoughi Univercity of Medical Sciences,Shahid Sadoughi Boulevard, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Diabetes Research Center of Yazd Shahid Sadoughi Univercity of Medical 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
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Nayereh Parsaeyan
Position
M Sc, Instructor
Other areas of specialty/work
Street address
Biochemistry Department, Pardis of Shahid Sadoughi Medical College, Shahdidan Gomnam Boulvard, Safayeh, Yaz
City
Yazd
Postal code
Phone
+98 3538203401017
Fax
Email
n_parsaeyan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Nayereh Parsaeyan
Position
M.Sc in Biochemistry
Other areas of specialty/work
Street address
Pardis of Yazd Shahid Sadoughi Medical College,Shahidan Gomnam Bboulevard, Safayeh, Yazd
City
Yazd
Postal code
Phone
+98 3538203401017
Fax
Email
n_parsaeyan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Nayereh Parsaeyan
Position
M.Sc, instructor
Other areas of specialty/work
Street address
Biochemistry Department, Pardis of Shahid Sadoughi Medical College, Shahidan Gomnam Boulevard, Safayeh, Yazd
City
Yazd
Postal code
Phone
+98 3538203401017
Fax
Email
n_parsaeyan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)