Protocol summary

Summary
Objective: Evaluation of the effects of camel milk compared with cow milk intake on glucose and insulin concentrations in patients with type 2 diabetes. Design: Randomized, Single blind Setting and conduct: A- Participants including major eligibility criteria - Major inclusion criteria: Patients with type 2 diabetes - Major exclusion criteria: Insulin ihjection and having cardiovascular and renal diseases - Sample size: 40 B- Intervention: 500 cc camel or caw milk C- Intervention Time: Evaluation of changes in glucose and insulin concentrations in 15, 30, 60, 120, and 180 minutes after consuming milk D- Main outcome: Blood sugar and insulin

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201302024794N6
Registration date: 2013-02-18, 1391/11/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-02-18, 1391/11/30
Registrant information
Name
Fereidoun Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 9309
Email address
azizi@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research Institute for Endocrine Science, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-08-21, 1392/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of changes in serum glucose and insulin concentrations following camel milk intake in type 2 diabetic patients
Public title
camel milk and changes in serum glucose
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with type 2 diabetes; age range: 20 to 70 years old; treatment with diet or oral anti-diabetic drugs. Exclusion Criteria: Treatment with insulin; pregnancy or lactation; smoking and alcohol consumption; body mass index greater than 35 kg/m2 ; Lactose intolerance; taking estrogenic drugs and corticosteroids; having cardiovascular disease, liver, lung, kidney and Chronic gastrointestinal and thyroid dysfunction; following from the weight loss diets two months prior to study; weight changes (increase or decrease) more than 5 kg two months prior to study.
Age
From 20 years old to 70 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)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee, Research Institute For Endocrine Sciences, Shahid Beheshti University of Medical S
Street address
Chamran Exp, Yemen street, Shahid Aerabi street, NO. 24
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
07/09/91 EC 425

Health conditions studied

1

Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Blood glucose
Timepoint
Fasting and 15, 30, 60, 120, and 180 minutes after consuming milk
Method of measurement
Biochemical analysis

2

Description
Insulin
Timepoint
Fasting and 15, 30, 60, 120, and 180 minutes after consuming milk
Method of measurement
Biochemical analysis

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: camel milk, 500 cc
Category
Other

2

Description
Control group: cow milk, 500 cc
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Institute for Endocrine Science, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fereidoun Azizi
Street address
Research Institute For Endocrine Sciences, NO. 24, Shahid Aerabi st, Yemen st, Chamran Exp
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical
Full name of responsible person
Fereidoun Azizi
Street address
Research Institute For Endocrine Sciences, NO. 24, Shahid Aerabi st, Yemen st, Chamran Exp
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 Institute for Endocrine Sciences, Shahid Beheshti University of Medical
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
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fereidoun Azizi
Position
Ph.D of Endocrine Sciences
Other areas of specialty/work
Street address
Research Institute For Endocrine Sciences, NO. 24, Shahid Aerabi st, Yemen st, Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
azizi@endocrine.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fereidoun Azizi
Position
Ph.D of Endocrine Sciences
Other areas of specialty/work
Street address
Research Institute For Endocrine Sciences, NO. 24, Shahid Aerabi st, Yemen st, Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
azizi@endocrine.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti
Full name of responsible person
Hanieh Sadat Ejtahed
Position
MSc of Nutrition Science
Other areas of specialty/work
Street address
Research Institute For Endocrine Sciences, NO. 24, Shahid Aerabi st, Yemen st, Chamran Exp
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
haniejtahed@yahoo.com
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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