This study is a randomized clinical trial . Population of diabetic patients attending a diabetes clinic in the city of Gorgan in 1392 are. A total of 90 patients according to the inclusion criteria will be randomly selected . Data collection included demographic form that included demographic and clinical are two parts . Subjects randomly assigned to intervention and control groups will be . During the 4 -week study , the control group did not receive any of our species and its previous routine compliance regime Knndvafrad daily treatment group, 2.5 % fat yoghurt 100g packages would consume probiotics . Measure blood sugar and blood pressure and Biological Indicators two sessions will be conducted and will be recorded . Blood samples will be taken at the beginning and end of the study
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404185866N18
Registration date:2014-11-05, 1393/08/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-05, 1393/08/14
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
Golestan University of Medical Sciences
Expected recruitment start date
2014-09-09, 1393/06/18
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic yogurt blood suger and cardiovascular biomarkers in patient type II diabetes clinic in Gorgan city in 2014
Public title
Effect probiotic yogurt on patients with diabet type 2
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: people are choosing which cases are active and are cilinic 5 Azar hospital diabetes the last test in case of non-fasting plasma glucose and fasting plasma glucose greater than 110 or greater than 200; more than a year has passed since the diabetes pill Metformin and Glibeclamid consume or use insulin; not suffering from an advanced form of the disease known vital organs and mental disorders; age between 30 to 70 years old and living in Gorgan.
Exclusion criteria: Patients who for any reason are excluded during the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Golestan University of Medical Sciences Ethics Committee
Street address
Golestan University of Medical Sciences, Shastkola
City
Gorgan
Postal code
Approval date
2014-06-08, 1393/03/18
Ethics committee reference number
13930318445
Health conditions studied
1
Description of health condition studied
Diabet
ICD-10 code
IV
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
TG
Timepoint
The beginning of the study, and 4 weeks later
Method of measurement
Taking a blood sample and send to the laboratory
2
Description
cholestrol
Timepoint
The beginning of the study, and 4 weeks later
Method of measurement
Taking a blood sample and send to the laboratory
3
Description
HBA1C
Timepoint
The beginning of the study, and 4 weeks later
Method of measurement
Taking a blood sample and send to the laboratory
4
Description
LDL
Timepoint
The beginning of the study, and 4 weeks later
Method of measurement
Taking a blood sample and send to the laboratory
5
Description
HDL
Timepoint
The beginning of the study, and 4 weeks later
Method of measurement
Taking a blood sample and send to the laboratory
6
Description
Fasting Blood Suger
Timepoint
The beginning of the study, and 4 weeks later
Method of measurement
Taking a blood sample and send to the laboratory
Secondary outcomes
1
Description
Blood Pressure
Timepoint
Before and after study
Method of measurement
Blood pressure device
2
Description
CRP
Timepoint
Before and after intervention
Method of measurement
Venous blood samples
Intervention groups
1
Description
Intervention group: blood samples will be taken at the beginning study; measures HBA1C, TG, cholesterol, LDL, HDL, fasting blood suger, CRP, blood pressure and then 4-week intake yogurt probiotics(2.5 % fat), 100g packages three times a day. At the end of the study ,after 4 weeks repeated tests and examine the effects of yogurt probiotics.
Category
Other
2
Description
Control group: blood samples will be taken at the beginning study; measures HBA1C, TG, cholesterol, LDL, HDL, fasting blood suger, CRP, blood pressure and then 4-week intake usual yogurt(2.5 % fat), 100g packages three times a day. At the end of the study, after 4 weeks repeated tests and examine the effects of usual yogurt.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center Diabetes Center of Gorgan
Full name of responsible person
Mahin Rezaei
Street address
Gorgan meeting 4
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Science, Research & Technology
Full name of responsible person
Doctor Masood Khoshnya
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
Golestan University of Medical Science, Research & Technology
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
Mahin.Rezaei
Position
Ms Student of Critical Nursing Care
Other areas of specialty/work
Street address
Bouyeh School of Nursing & Midwifery, Golestan University of Medical Sciences. Shastkola
City
Gorgan
Postal code
Phone
+98 17 1337 6119
Fax
Email
mahin.rezaei@ymail.com
Web page address
www.goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing Research Center, Golestan University of Medical Sciences
Full name of responsible person
Dr Akram Sanagoo
Position
PhD
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
sanagoo@goums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing Research Center, Golestan University of Medical Sciences
Full name of responsible person
Akram Sanagoo
Position
PhD of NUrsing Education, Dean of NUrsing Research Center
Other areas of specialty/work
Street address
Nursing Research Center ,Golestan University of Medical Sciences,Shastkola
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
Email
sanagoo@goums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)