The effect of carnosine supplementation on advanced glycation endproductsandtheir soluble reseptor, metabolic condition and oxidative indices in type2 diabetic patients
The current Randomized double blind placebo controlled study will be conducted on type 2 diabetic patients with the aim of studing effect of carnosine supplementation on advanced glycation end productsandtheir soluble reseptor, metabolic condition and oxidative indices. 44 patients will randomly be allocated 2 groups: 1- study group (reciving carnosine) 2- control group(receiving placebo). Study group will receive daily 2 capsules of 500 mg carnosine for 3 month and control group will receive micro crystalline cellulose for 3 month.The questionnaires of general characters and food frequency will be completed by interview.Three days food record will be competed by patients. The biochemichal indices and Anthropometric measurements will be measured at baseline and at the end of the study.
: will be measured
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011211689N2
Registration date:2016-02-01, 1394/11/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-01, 1394/11/12
Registrant information
Name
Sorayya Kheirouri
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
kheirouris@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research and technology of Tabriz university of medical science
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of carnosine supplementation on advanced glycation endproductsandtheir soluble reseptor, metabolic condition and oxidative indices in type2 diabetic patients
Public title
The effect of carnosine supplementation in type 2 diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusuion criteria: : 1- Patients with type 2 diabetes age:30-60 2- patients using oral agents 3-BMI<40
Exclusion criteria: 1-BMI>40 2- inflammatory and alergic disease 3-menopause 4- use of multivitamine-mineral 3 month prior to the study 4- use of corton or anti inflammetory steroid drugs 4- change in dosage of bloos sugar lowering drugs 5- chang in physical activity (duration and intensity) 6-use of insulin 7- patients affected with Poly cystic ovary syndrome 8- cardiovascular, kidney, liver disaese (exept fatty liver),9-hypo and hypertyroidism 9- Pregnency and lactation
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical science
Street address
Golgasht street/central bulilding/ 3th floor
City
Tabriz
Postal code
Approval date
2015-12-13, 1394/09/22
Ethics committee reference number
TBZMED.REC.1394.854
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
srume pentosidine
Timepoint
prior to the study and 3 month after
Method of measurement
ElISA
2
Description
Carboxymethyllysine
Timepoint
prior to the study and 3 month after
Method of measurement
ElISA
3
Description
sRAGE
Timepoint
prior to the study and 3 month after
Method of measurement
ElISA
4
Description
TG-Total cholestrol-LDL- HDL
Timepoint
prior to the study and 3 month after
Method of measurement
ElISA
5
Description
Fasting blood suger
Timepoint
prior to the study and 3 month after
Method of measurement
Enzymetic method
6
Description
Insuline
Timepoint
prior to the study and 3 month after
Method of measurement
ElISA
7
Description
HOMA score
Timepoint
prior to the study and 3 month after
Method of measurement
Insulin (mU/L) * FSG(mmol/L) /22.5
8
Description
HbA1c
Timepoint
prior to the study and 3 month after
Method of measurement
HPLC chromatography
9
Description
Total Antioxidant Capacity
Timepoint
prior to the study and 3 month after
Method of measurement
spectrophotometry
10
Description
malondialdehyde
Timepoint
prior to the study and 3 month after
Method of measurement
spectrophotometry
11
Description
superoxide dismutase
Timepoint
prior to the study and 3 month after
Method of measurement
spectrophotometry
12
Description
catalase
Timepoint
prior to the study and 3 month after
Method of measurement
spectrophotometry
13
Description
Nitric oxide
Timepoint
prior to the study and 3 month after
Method of measurement
spectrophotometry
14
Description
Protein carbonil
Timepoint
prior to the study and 3 month after
Method of measurement
spectrophotometry
Secondary outcomes
1
Description
systolic diastolic blood pressure
Timepoint
prior to the study and 3 month after
Method of measurement
Digital manometer
Intervention groups
1
Description
Carnosine capsule (500 mg, twice daily, totall dose of 1000 mg, for 3 month)
Category
Other
2
Description
placebo capsule (micro crystalline cellulose )
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology clinic
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research and technology of Tabriz university of medical science
Full name of responsible person
Mohammad Reza Rashidi
Street address
Golgasht street/central bulilding/ 3th floor
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology of Tabriz university of medical science
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
Tabriz university of Medical science
Full name of responsible person
Shiva Hoojeghani
Position
PhD fellow of nutrition
Other areas of specialty/work
Street address
Golghasht street-Atter Neyshabouri avenue-Faculty of nutrition
City
Tabriz
Postal code
Phone
+98 41 3335 7581
Fax
Email
Shiva.hoojeghani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical science-nutrition faculty
Full name of responsible person
Dr. Sorayya kheirouri
Position
PhD of nutrition- Associate Professor
Other areas of specialty/work
Street address
Golghasht street-Atter Neyshabouri avenue-Faculty of nutrition
City
Tabriz
Postal code
Phone
+98 41 3335 7580
Fax
Email
kheirouris@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Shiva Hoojeghani
Position
Other areas of specialty/work
Street address
Golghasht street-Atter Neyshabouri avenue-Faculty of nutrition
City
Postal code
Phone
00
Fax
Email
shiva.hoojeghani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)