The main purpose of this study is to investigate the effect of combined aerobic exercise and barley β-glucan on lipid profile and blood glucose of women with diabet type two. Design and method of study: This study is an interventional and not blinded research. Twenty- four female volunteers, with age average 49 years fasting blood glucose between 110- 280 mg.dL-1 are selected purposefully and after completion of questionnaires, are selected and randomly (based on random numbers table) will be divided into three groups of 8 participants: aerobic training with diet, diet and control groups. The group diet use one number bread with 4 gram barley every day for 12 week. The aerobic training with diet group in addition to participate in weekly group sessions for diet (barley bread) took part advanced walking session aerobic training program with intensity 60-70 pertcent of maximal heart rate; 2 to 3 times in week and the duration of each time was 20-60 minutes in 12 week. In the control group, activity is not performed regularly. Inclusion Criteria: Suffering from type 2 diabetes; blood glucose between 110- 280 mg.dL-1. Exclusion criteria: any acute disease during the study period; Absence from a training protocol session. Primary outcome: the blood glucose, triglyceride, cholesterol, LDL and HDL will be evaluated 24 hours before and 48 hours after training program.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041933542N1
Registration date:2017-11-08, 1396/08/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
Fatemeh Mokhtari
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3793 2571
Email address
f.esfarjani@ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University
Expected recruitment start date
2012-12-05, 1391/09/15
Expected recruitment end date
2013-03-05, 1391/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined aerobic exercise and barley β-glucan on lipid profile and blood glucose of women with diabet type two
Public title
Effects of exercise and consumption of barley bread on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: suffering from type 2 diabetes; blood glucose between 110- 280 mg.dL-1 Exclusion criteria: any acute disease during the study period; Absence from a training protocol session
Age
From 35 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
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
Ethics Committee of Esfahan university
Street address
Isfahan University, Hezar jarib St, Isfahan
City
Esfahan
Postal code
Approval date
2012-11-30, 1391/09/10
Ethics committee reference number
IR.MUI.REC.1391.4.001
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
Glucose blood
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Blood test
2
Description
Lipid profiles (TG, TC, HDL-C and LDL-C)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The aerobic training with diet group in addition to participate in weekly group sessions for diet (barley bread) took part advanced walking session aerobic training program with intensity 60-70 pertcent of maximal heart rate; 2 to 3 times in week and the duration of each time was 20-60 minutes in 12 week.
Category
Other
2
Description
Intervention group 2: The group diet use one number bread with 4 gram barley every day for 12 week.
Category
Other
3
Description
Control group: In the control group, activity is not performed regularly.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Charity of Hazrat Vale Asr
Full name of responsible person
Fatemeh Mokhtari
Street address
Jabal Ameli St, Kozeh Square, khomeini Shahr
City
Khomeini Shahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Esfahan University
Full name of responsible person
Dr Fahimeh Esfarjani
Street address
Isfahan University, Hezar jarib St, Isfahan
City
Esfahan
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, Esfahan University
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
University of Isfahan
Full name of responsible person
Fatemeh Mokhtari
Position
MS in Exercise Physiology
Other areas of specialty/work
Street address
Isfahan University, Hezar jarib St, Isfahan
City
Isfahan
Postal code
81746-73441
Phone
+98 31 3793 4283
Fax
Email
Fa.moztar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Fatemeh Mokhtari
Position
MS in Exercise Physiology
Other areas of specialty/work
Street address
Isfahan University, Hezar jarib St, Isfahan
City
Esfahan
Postal code
Phone
+98 31 3793 4283
Fax
Email
Fa.moztar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Fatemeh Mokhtari
Position
MS in Exercise Physiology
Other areas of specialty/work
Street address
Isfahan University, Hezar jarib St, Isfahan
City
Isfahan
Postal code
81746-73441
Phone
+98 31 3793 4283
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)