The objective of this randomized, not blinded trial is to investigate the effect of Vit D on adiponectin plasma levels in first-degree relatives of diabetic patients . In this study, 64 first-degree relatives of diabetic patients who meet the inclusion/exclusion criteria will be recruited and randomly assigned into the intervention or control group. The participants in the intervention group will receive 50000 IU Vit D weekly for 12 weeks. The participants in the control group will receive no intervention. We recommend regular exercise and weight control in the two groups. Fasting blood glucose, 2 hours post prandial glucose, triglyceride, cholesterol, LDL, HDL, insulin, HOMA Index and adiponectin will be measured before and after the intervention and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105176430N1
Registration date:2011-07-26, 1390/05/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-26, 1390/05/04
Registrant information
Name
Seyed Mohammad Mohammadi-zarch
Name of organization / entity
Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1522 3999
Email address
m_mohammadi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-07-23, 1389/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vit-D on adiponectin plasma levels and insulin resistance in first-degree relatives of diabetic patients
Public title
The effect of Vit-D on adiponectin plasma levels and insulin resistance in first-degree relatives of diabetic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: First-degree relatives of diabetic patients; BMI >25kg/m2; age between 25-65 years. Exclusion criteria: Diabetic patients; who has consumed Vit-D supplementation or Metformin for past three months.
Age
From 25 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahid Sadoughi University of Medical sciences
Street address
Bahonar Square
City
Yazd
Postal code
8916978477
Approval date
2010-03-13, 1388/12/22
Ethics committee reference number
118101/1/17/پ
Health conditions studied
1
Description of health condition studied
First degree Relatives of Diabetic Patients
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Insulin
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Insulin Kit and the Unit is mu/lit
2
Description
Adiponectin
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Adiponectin kit and the unit is ng/ml
Secondary outcomes
1
Description
FBS
Timepoint
12 weeks
Method of measurement
Measurement of blood glucose by Auto analyzer method
2
Description
2hpp
Timepoint
12 weeks
Method of measurement
Measurement of blood glucose by Auto analyzer method
3
Description
TG
Timepoint
12 weeks
Method of measurement
Measurement of triglyceride by Auto Analyzer method
4
Description
Cholesterol
Timepoint
12 weeks
Method of measurement
Measurement of cholestrol by Auto nalyser method
5
Description
HDL
Timepoint
12 weeks
Method of measurement
Measurement of HDL by Auto Analyser method
6
Description
LDL
Timepoint
12 weeks
Method of measurement
Measurement of LDL by Auto Analyser method
Intervention groups
1
Description
Intervention group will cosume 50000 IU Vit D weekly for 12 weeks
Category
Treatment - Drugs
2
Description
Control group will receive nothing
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetic Research Center, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Seyed Ahmad Eghbali Zarch
Street address
Afshar Alley, Jomhouri Blvd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical sciences, Yazd Diabetes Research Center
Full name of responsible person
Dr.Mohammad Afkhami-Ardekani
Street address
Afshar Alley, Jomhouri Blvd.
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical sciences, Yazd Diabetes Research Center
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 Diabetes Research Center, Shahid Sadooghi University of Medical Sciences
Full name of responsible person
Seyed Ahmad Eghbali zarch
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Yazd Diabetes Research Center, Afshar Alley, Jomhouri Blvd
City
Yazd
Postal code
8917965556
Phone
+98 35 1522 3999
Fax
+98 35 1525 8354
Email
drc@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mohammad Mohammadi Zarch
Position
Assistant professor of Endocrinology
Other areas of specialty/work
Street address
Yazd Diabetes Research Center, Afshar Alley, Jomhouri Blvd.
City
Yazd
Postal code
891796556
Phone
+98 35 1522 3999
Fax
+98 35 1525 8354
Email
mohammadizarch@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Seyed Ahmad Eghbali Zarch
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Yazd Diabetes Research Center, Afshar Alley, Jomhouri BLV., Yazd, Iran
City
Yazd
Postal code
891796556
Phone
+98 913 153 3990
Fax
+98 35 1525 8354
Email
drc@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)