Protocol summary

Summary
The point of this plan is finding out chromium effect on diabetes based on metabolic indices such as BS, TG, Cholesterol, LDL, HDL, HbA1c, weight and BMI. Design: Randomized, double blind, placebo controlled, one central. Inclusion criteria: 7%≤HbA1c≤10, 25≤BMI≤35, DM2, having stability of anti diabetic treatment during 3 month, having 30 to 65 years old. They will be excluded from the study in the case of having Cr>1.5 for male and Cr>1.4 for female, liver enzymes (Alt, Ast) more than two upper limit normal, pregnancy, heart failure, chronic liver disease, uncontrolled hypertension, immunosuppressive disease or immunosuppressive treatment, alcohol use and other drug abuse, psychological unhealthy, confined to bed during recent 1 years. In this research 60 type2 diabetic patients will be choosen for administration of 200 micro grams chromium picolinate tablet (intervention group) or placebo (control group) during 3 months then we will measure index of HbA1c, LDL, HDL, TG, Cr, FBS, Bs2hpp, Uric acid, Alt, Ast, BMI before and 3 month after intervention and the results will be compared for this two groups based on response the treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013012812311N1
Registration date: 2013-03-07, 1391/12/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-03-07, 1391/12/17
Registrant information
Name
Azam Erfanifar
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4484 7836
Email address
erfanifarazam@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigators
Expected recruitment start date
2012-05-14, 1391/02/25
Expected recruitment end date
2012-09-08, 1391/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of chromium on the metabolic index in patients with diabetes mellitus type2
Public title
Effect of chromium on diabetes mellitus type2 treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. HbA1c≤10%, HbA1c≥7%; 2. DM2; 3. BMI≤35, BMI≥25; 4. Stability of antidiabetic treatment during recent 3 mounths; 5. Age 30-65 years. Exclusion criteria: 1. Cr˃1.5 (men), Cr>1.4 (female); 2. Liver function test (ALT, AST) >2 fold of upper limit normal; 3. Pregnancy; 4. Heart Failure; 5. Chronic Liver disease; 6. Uncontrolled hypertension; 7. Immunosupression disease and immunosupresive therapy; 8. Alcohol use and other drug abuse; 9. Psychological unhealthy; 10. Confined to bed during recent 1 years.
Age
From 30 years old to 65 years old
Gender
Both
Phase
2-3
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
Shahid Beheshti University of Medical Sciences
Street address
Velenjak-evin
City
Tehran
Postal code
Approval date
2012-05-13, 1391/02/24
Ethics committee reference number
117

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Uric acid
Timepoint
Before intervension & 3 months later
Method of measurement
mg/dl- labratory kit

2

Description
HbA1c
Timepoint
Before intervension & 3 months later
Method of measurement
mg/dl- labratory kit

3

Description
HDL- C
Timepoint
Before intervension & 3 months later
Method of measurement
mg/dl- labratory kit

4

Description
LDL- C
Timepoint
Before intervension & 3 months later
Method of measurement
mg/dl- labratory kit

5

Description
TG
Timepoint
Before intervension & 3 months later
Method of measurement
mg/dl- labratory kit

6

Description
FPG
Timepoint
Before intervension & 3 months later
Method of measurement
mg/dl- labratory kit

7

Description
BS 2hpp
Timepoint
Before intervension & 3 months later
Method of measurement
mg/dl- labratory kit

8

Description
BMI
Timepoint
Before intervension & 3 months later
Method of measurement
kg/m2

9

Description
Creatinine
Timepoint
Before intervension & 3 months later
Method of measurement
mg/dl- labratory kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: chromium picolinat 200 microgram tablet, once daily during 3 mounth.
Category
Treatment - Drugs

2

Description
control group: placebo, once daily during 3 mounth.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hospital
Full name of responsible person
Dr. Saeid Kalbasi
Street address
Makhsous Ave, Lashkar Croosroads, South Kargar Ave.
City
Tehran

2

Recruitment center
Name of recruitment center
Taban Clinck of Diabetic disease Control
Full name of responsible person
Dr. Saeid Kalbasi
Street address
No 100, north Derakhti Blvd, shahid Dadman Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Private
Full name of responsible person
Doctor Azam Erfanifar
Street address
Tehran-Punak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Doctor Hosein Gudarzi
Street address
Velenjak- Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Doctor Azam Arfanifar
Position
Internal Medicine resident
Other areas of specialty/work
Street address
Loghman Hospital
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
Email
erfanifarazam@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Doctor Azam Erfanifar
Position
Internal Medicine resident
Other areas of specialty/work
Street address
Makhsous Ave. Lashkar crossroad
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
Email
erfanifarazam@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Loghman Hospital
Full name of responsible person
Mina Moradi
Position
Msc of Nutrition
Other areas of specialty/work
Street address
Makhsous Ave, Lashkar crossroad
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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