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Effects of resistance training and exercise in water on visfatin and insulin levels in women with gestational diabetes

Protocol summary

Summary
The purpose of this study was to determine the effect of aerobic and resistance exercise on serum levels of visfatin, insulin sensitivity, glycosylated hemoglobin, serum glucose and insulin resistance in women with gestational diabetes. The 45 women with gestational diabetes, with an age range of 20 to 35 years and 21 to 27 weeks gestational age, which have not a barrier to doing physical activity, Voluntarily entered the study. In the first, subjects voluntarily divided to aerobic exercise, resistance training and control groups before Began Interventions and after 8 weeks the intervention, will be taken 10 cc of blood to measure factors visfatin, insulin sensitivity, glycosylated hemoglobin, insulin resistance and blood sugar levels. Assessment resulting from a blood test will show whether physical activity has a positive effect or not and which type of activity is effective as an adjunctive therapy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014031717035N1
Registration date: 2015-04-03, 1394/01/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-04-03, 1394/01/14
Registrant information
Name
Maryam Kasraeian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 32365
Email address
kasraeem@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-01-20, 1393/10/30
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of resistance training and exercise in water on visfatin and insulin levels in women with gestational diabetes
Public title
Effect of Exercise on gestational diabetes
Purpose
Health service research
Inclusion/Exclusion criteria
(Inclusion criteria: Women with gestational diabetes1; In the 21 to 28 weeks of their pregnancy; According to the guidelines of the American College of Obstetrics and Gynecology, they do not have any absolute prohibition of the exercise; Age: 20 to 35 years of age; they do not use smoking, drugs and alcohol; they are untrained Exclusion criteria: People with a history of proven infectious diseases and autoimmune diseases such as lupus Eratosthenes and rheumatoid arthritis, thyroid disease, epilepsy, high blood pressure, leg pain, cervical insufficiency, anemia or other blood disorders, bleeding during pregnancy, placenta previa, respiratory problems, heart disease or any heart disease, obesity or excessive weight loss and Any disease that can be prevented the exercise, have be excluded from the study)
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
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

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Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University Of Medical Science
Street address
Building of Shiraz University Of Medical Science, Zand street, Shiraz
City
Shiraz
Postal code
Approval date
2015-01-05, 1393/10/15
Ethics committee reference number
CT-P-9378-7928

Health conditions studied

1

Description of health condition studied
Gesttational diabets
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in pregnancy, Gestational diabetes mellitus NOS

Primary outcomes

1

Description
Enterlucin serm
Timepoint
Before intervntion and after 8 weeks intervention
Method of measurement
Kit

2

Description
- Exercise intensity
Timepoint
Before intervntion and after 8 weeks intervention
Method of measurement
Is measured according to the Rating of perveived exertion (RPE).

3

Description
Visfatin Serum
Timepoint
Before intervntion and after 8 weeks intervention
Method of measurement
Kit

4

Description
Insulin sensitivity
Timepoint
Before intervntion and after 8 weeks intervention
Method of measurement
Kit

5

Description
Glycosylated hemoglobin
Timepoint
Before intervntion and after 8 weeks intervention
Method of measurement
Kit

6

Description
Insulin resistance and serum glucose
Timepoint
Before intervntion and after 8 weeks intervention
Method of measurement
Kit

Secondary outcomes

1

Description
Nutrition
Timepoint
Before the research began
Method of measurement
Fed with the same diet

2

Description
Activity level before sampling
Timepoint
Before the research began
Method of measurement
level of physical activity using a physical activity questionnaire

Intervention groups

1

Description
Control group: This group is not just any kind of sporting activity takes place in the routine treatment.
Category
Other

2

Description
Intervention group: This group is for 8 weeks, 3 sessions of 45 minutes of physical activity per week (water sports and clubs) are given.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Dr nasibe kazemi
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed basir hashemi
Street address
7th Floor dean of research, Building of University Of Medical Sciences, Zand
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University Of Medical Sciences
Full name of responsible person
Dr Nasebe kazemi
Position
Student
Other areas of specialty/work
Street address
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3628 1591
Fax
Email
nasibe.kazemi@yahoo.com
Web page address
perinatalrc.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Kasraeian
Position
Assistant professor
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
Email
kasraeemm@yahoo.com; hafez_perina@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Maternal-fetal medicine Research Center
Full name of responsible person
Khadije Bazrafshan
Position
Master
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 7136271531257
Fax
Email
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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