The objective of this double blind placebo-controlled trial is to investigate the effects of selenium on oxidative stress and glycemic control of type 2 diabetes. Sixty patients with type 2 diabetes who meet the eligibility criteria will be recruited and after signing the informed consent assigned randomly (block randomization) to receive selenium (200 micg/d) or placebo for 12 weeks. HgA1c, FBS, fasting plasma insulin level, plasma selenium level, lipid profil, and oxidative stress level at the baseline and the end of the study period. Compliance (pill counting) and patient’s general condition are evaluated at the 6th week of the study. Insulin resistance will be measured by HOMA-IR method and oxidative stress will be measured by lipid oxidation via TBARS method and antioxidant capacity via FRAP method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901203667N1
Registration date:2010-02-20, 1388/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-20, 1388/12/01
Registrant information
Name
Mania Radfar
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
radfarma@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vive-chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2010-02-20, 1388/12/01
Expected recruitment end date
2010-11-22, 1389/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of selenium on oxidative stress and glycemic control of type 2 diabetes
Public title
Effects of selenium on oxidative stress and glycemic control of type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-70 years, FPG<250mg/dL & HgA1c <9%, not using insulin during past 8 weeks, signing the informed consent
Exclusion criteria: taking selenium supplements during the past 6 months, renal dysfunction (GFR less than 50ml/min), hepatic dysfunction (ALT, AST more than 3xULN), pregnancy, lactation, type 1 diabetes
Age
From 18 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Vice-chancellor for research, Tehran University of Medical Sciences
Street address
Central organization of Tehran University of Medical Sciences, Ghods avenue, Keshavarz Blvd,Tehran,
City
Tehran
Postal code
Approval date
2009-01-26, 1387/11/07
Ethics committee reference number
7709-33-03-87
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E10, E14
ICD-10 code description
Diabetes Mellitus
Primary outcomes
1
Description
controlling blood glucose
Timepoint
12 weeks
Method of measurement
A1c, FBG
2
Description
oxidative stess
Timepoint
12 weeks
Method of measurement
FRAP, TBARS
Secondary outcomes
1
Description
Lipid profile
Timepoint
12 weeks
Method of measurement
Total cholestrol, LDL, HDL, TG
2
Description
Inulin resistance
Timepoint
12 weeks
Method of measurement
HOMA-IR
Intervention groups
1
Description
200 microgram selenium daily for 12 weeks
Category
Treatment - Drugs
2
Description
one placebo capsule daily for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocinology and metabolism research center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Saeidi
Street address
central organization of Tehran University of Medical Sciences, Ghods avenue, Keshavrz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Tehran University 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Mania Radfar
Position
Assistant professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, faculty of Pharmacy, 16 azar avenue,
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
radfarma@tums.ac.ir; mania1352@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mania Radfar
Position
Assistant professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, faculty of Pharmacy, 16 Azar avenue,
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
radfarma@tums.ac.ir; mania1352@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mania Radfar
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, faculty of Pharmacy, 16 azar avenue,
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
radfarma@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)