Protocol summary

Summary
The purpose of present study was to investigate the effect of Barberry juice on serum glucose, lipids, apolipoproteins and paraoxonase 1 levels and blood pressure in patients with type 2 diabetes. Inclusion criteria : Willingness to work, have type 2 diabetes, Not using insulin and Exclusion Criteria : recurrent disease as the leading cause of hospitalization; changing The type and dose of medication of patients. The study population are 46 patients with type 2 diabetes. Patients in the intervention group receive 200 cc Barberry juice daily for 8 weeks. control group receive no action . at the beginning and end of the study Concentrations of total cholesterol and paraoxonase 1 serum Will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201409031640N14
Registration date: 2015-02-14, 1393/11/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-14, 1393/11/25
Registrant information
Name
Parvin Mirmiran
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
mirmiran@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Institute for Endocrine Sciences (Shahid Behesti University of Medical Sciences and Health Services), Research Institute of Nutrition and Food Technology
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of barberry juice on serum glucose, lipids, apopropteins, paraoxonase -1 and blood pressure in patients with type 2 diabetes
Public title
Effect of barberry juice on serum glucose, lipids, apopropteins, paraoxonase -1 and blood pressure in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to work; developing type 2 diabetes; Not using insulin; Body Mass Index> 18/5. Exclusion Criteria: recurrent disease as the leading cause of hospitalization; changing The type and dose of medication of patients
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
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
Research Institute of Nutrition and Food Technology
Street address
Shahrakgharb, Tehran
City
Tehran
Postal code
20/10/1391
Approval date
2013-03-12, 1391/12/22
Ethics committee reference number
048481

Health conditions studied

1

Description of health condition studied
Type 2 Diabetes
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
cholesterol
Timepoint
Before the intervention, after intervention
Method of measurement
Enzymatic method using kits

2

Description
Paraoxonase 1
Timepoint
Before the intervention, after intervention
Method of measurement
Enzymatic method using kits

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: Barberry Juice, 200 cc, 2 times daily. 8 weeks
Category
Lifestyle

2

Description
Control Group: No action
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Diabetes Society, Babol
Full name of responsible person
Fatemeh lazavi
Street address
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Institute for Endocrine Sciences (Shahid Behesti University of Medical Sciences and Health
Full name of responsible person
Dr Parvin Mirmiran
Street address
Research Institute for Endocrine Sciences (Shahid Behesti University of Medical Sciences and Health Services
City
Velenjak, Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Endocrine Sciences (Shahid Behesti University of Medical Sciences and Health
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
Shahid Behesti University of Medical Sciences and Health Services
Full name of responsible person
Fatemeh Lazavi
Position
Ms
Other areas of specialty/work
Street address
Shahid Behesti University of Medical Sciences and Health Services, nutrition depatment
City
Babol
Postal code
Phone
+98 11 3232 6045
Fax
Email
fatemelazavi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Institute for Endocrine Sciences (Shahid Behesti University of Medical Sciences and Health
Full name of responsible person
Dr Parvin Mirmiran
Position
PhD Nutrition
Other areas of specialty/work
Street address
Research Institute for Endocrine Sciences (Shahid Behesti University of Medical Sciences and Health Services)
City
Velenjak, Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
parvinmirmiran@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Research Institute for Endocrine Sciences (Shahid Behesti University of Medical Sciences and Health
Full name of responsible person
Dr Parvin Mirmiran
Position
PhD Nutrition
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
Fax
Email
parvinmirmiran@gmail.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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