The purpose of this study is assessing the effect of camel milk on glycemic control in patients with type 2 diabetes. This study is a randomized, double-blind clinical trial of 4 weeks with a sample size of 50 patients with type 2 diabetes, with a non-probability sampling in the first stage is available and will be assigned to intervention and control groups. The intervention group consisted of 25 patients in addition to diabetes treatment plan, camel milk per day at a rate of 500 ml (2 cups) given and the control group consisted of 25 patients given the same amount of milk. Intervention will continue for 4 weeks, fasting blood sample for testing of FBS at the end of the second week and the thirtieth day will be collected. Check two-hour glucose Pd breakfast and HBA1c testing is done after the fourth week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308265866N15
Registration date:2014-09-22, 1393/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-22, 1393/06/31
Registrant information
Name
Akram Sanagoo
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1443 0360
Email address
sanagoo@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing Research Center, Golestan University of Medical Sciences (Student Research Committee)
Expected recruitment start date
2014-09-09, 1393/06/18
Expected recruitment end date
2015-03-03, 1393/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of camel milk on glycemic control in type 2 diabetic patients referred to hospital Sayyad Shirazi in 2013
Public title
Effect of camel milk on glycemic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all subjects with type 2 diabetes aged 18-80 years old. Exclusion criteria: Diabetics taking insulin for diabetes complications such as Hyperglycemia diabetic ketoacidosis, acute kidney infections, nephropathy, neuropathy or severe heart disease.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Sciences Ethics Committee
Street address
Gorgan, shastkola,Golestan University
City
gorgan
Postal code
4934174515
Approval date
2014-06-29, 1393/04/08
Ethics committee reference number
930408454
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
HbA1c
Timepoint
At the begining, second week, fourth week
Method of measurement
Tool in the laboratory
2
Description
Blood glucose
Timepoint
At the begining, second week, fourth week
Method of measurement
Scale for blood glucose (glucometer)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: consisted of 25 patients in addition to diabetes treatment plan, camel milk per day at a rate of 500 ml (2 cups) given and the Intervention will continue for 4 weeks
Category
Treatment - Other
2
Description
The control group: consisted of 25 patients given the same amount of milk will continue for 4 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sayad Shirazi Hospital
Full name of responsible person
Mahdie Margdari Nejad
Street address
Shahid Sayad Shirazi Hospital, Gorgan, Golestan
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research & Technology, Golestan University of Medical Sciences
Full name of responsible person
Masood Khoshnia
Street address
Deputy of Research & Technology, Golestan University of Medical Sciences,Shastkola
City
Gorgan
Grant name
مرکز تحقیقات
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research & Technology, Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Mahdie Margdari Nejad
Position
MSc student of nursing
Other areas of specialty/work
Street address
Bouyeh School of Nursing & Midwifery, Golestan University of Medical Sciences. Shastkola
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
Email
mahdie.margdari@yahoo.com
Web page address
www.goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr. Samira Eshghi Nia
Position
PhD of nutrition
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, Shastkola
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
Email
dreshghinia@yahoo.com
Web page address
www.Goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mahdie Margdari Nejad
Position
MSc student of nursing
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, Shastkola
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
mahdie.margdari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)