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A survey effect of chromium picolinate on glycemic control in type 2 diabetic patients

Protocol summary

Summary
This is a prospective, double blind randomized and placebo controlled trial which survey effect of chromium picolinate on FBS, HbA1C, lipid profile, serum chromium level, and BMI in type 2 diabetic patients. A total of 40 patients with type 2 diabetes who are poor controlled with oral hypoglycemic agents will be enrolled. The patients will be randomly assigned to receive 200 micrograms per day of chromium picolinate or placebo, once daily for 3 months. Placebo will be made of all ingredients of chromium picolinate manufactured by 21st century co. unless chromium element. After 3 months, FBS, HbA1C, lipid profile, BUN, Cr, serum chromium level, and BMI will be checked again and the changes before and after treatment will be evaluated between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201009264817N1
Registration date: 2010-10-16, 1389/07/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-10-16, 1389/07/24
Registrant information
Name
Sara Saffarian
Name of organization / entity
Medical Resident
Country
Iran (Islamic Republic of)
Phone
+98 61 1221 6553
Email address
sarasaffarian@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University Of Medical Sciences
Expected recruitment start date
2010-05-02, 1389/02/12
Expected recruitment end date
2010-11-01, 1389/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey effect of chromium picolinate on glycemic control in type 2 diabetic patients
Public title
Effect of chromium administration in controlling blood sugar in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: type 2 diabetic patients with HbA1C>7% Exclusion criteria: renal, hepatic, or heart failure
Age
From 30 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
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, Ahvaz Jundishapur University
Street address
Ahvaz Jundishapur University
City
Ahvaz
Postal code
Approval date
2010-07-07, 1389/04/16
Ethics committee reference number
1848/20/8/پ

Health conditions studied

1

Description of health condition studied
Diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
HbA1C
Timepoint
at first and 3 months later
Method of measurement
HPLC

2

Description
FBS
Timepoint
at first and 3 months later
Method of measurement
R-1000 device

Secondary outcomes

1

Description
BMI
Timepoint
At first and 3 month later
Method of measurement
weight/height2

2

Description
Serum chromium level
Timepoint
at first and 3 months later
Method of measurement
Atomic absorption spectrophotometry

3

Description
serum lipids
Timepoint
At first and 3 months later
Method of measurement
Direct LDL-Chol

Intervention groups

1

Description
chromium picolinate 200 microgram daily for 3 months
Category
Treatment - Drugs

2

Description
Placebo once daily for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Sara Saffarian
Street address
Golestan Hospital, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy, Jundishapur University Of Ahvaz
Full name of responsible person
Dr. Peyman Payami
Street address
Ahvaz Jundishapur University Of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy, Jundishapur University Of Ahvaz
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
Jundishapur University
Full name of responsible person
Dr. Sara Saffarian
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Ahvaz Jundishapur Medical University
City
Ahvaz
Postal code
Phone
+98 61 1374 3013
Fax
Email
sarasaffarian@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University
Full name of responsible person
Dr. Peyman Payami
Position
Assistant Professor Of Endocrine
Other areas of specialty/work
Street address
Internal Medicine Ward, Golestan Hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1221 6553
Fax
Email
peyman_payami1@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University
Full name of responsible person
Dr. Sara Saffarian
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Golestan Hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1221 6553
Fax
Email
sarasaffarian@ajums.ac.ir
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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