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Effect of aerobic exercise and 25 hydroxy vitamin D supplementation on ratio of GLP1 and DPP4 and Insulin resistance In men with type 2 diabetes

Protocol summary

Summary
Objectives: The objective of this study was to investigate the effect of 8 weeks of aerobic training With and without 25-Hydroxy Vitamin D Supplementation on level of GLP1 and DPP4 Serum, Fasting Blood Sugar, Serum Insulin and Insulin Resistant index in Patients with Type 2 Diabetic. Design:This research will be pre test-post test with control group design. Setting and conduct: Among men 40 to 60 years with type 2 diabetes admitted Jesus, son of Mary Hospital in Isfahan, a number of 48 persons voluntarily and in access choice were put in four groups of Aerobic exercise group (12patients), aerobic exercise with 25-Hydroxy Vitamin D supplementation group(12patients), 25-Hydroxy Vitamin D supplementation group (12patients) and control group(12patients). Participants including major eligibility criteria: All men with type 2 diabetes who referred to diabetes admitted Jesus, son of Mary Hospital that number 48 people, has a presence in study,Including Aged 40 to 60 years؛ Not doing regular physical activity؛ Do not use Insulin؛ Lack of complications of diabetes Including Diabetic foot ulcers؛ Blood glucose less than250(mg/dl)؛ HBA1C Less than 8, choice and put in four groups of Aerobic exercise group (12patients), aerobic exercise with 25-Hydroxy Vitamin D supplementation group(12patients), 25-Hydroxy Vitamin D supplementation group (12patients) and control group(12patients). Intervention: Exercise program was include 8 weeks (3sessions in week, each session 60-75 minutes, the intensity of exercise was 60 to 80 percent of maximum heart rate). supplemented groups also received 50000 units of oral vitamin D daily for 8 weeks. main outcome: Level of GLP1 and DPP4, Fasting Blood Sugar, Serum Insulin and Insulin Resistant

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017010315812N3
Registration date: 2017-03-08, 1395/12/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-08, 1395/12/18
Registrant information
Name
Naser Rahimi
Name of organization / entity
Hamedan University
Country
Iran (Islamic Republic of)
Phone
+98 813829614
Email address
n.rahimi2009@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Bu Ali Sina University in Hamedan
Expected recruitment start date
2017-01-14, 1395/10/25
Expected recruitment end date
2017-03-15, 1395/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aerobic exercise and 25 hydroxy vitamin D supplementation on ratio of GLP1 and DPP4 and Insulin resistance In men with type 2 diabetes
Public title
Effect of aerobic exercise and 25 hydroxy vitamin D supplementation on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Terms of enter the major conditions: Male؛ Type 2 diabetes Infection according to diagnosis and medical records for more than a year؛ Aged 40 to 60 years؛ Not doing regular physical activity؛ Do not use Insulin؛ Lack of complications of diabetes Including Diabetic foot ulcers؛ Blood glucose less than250(mg/dl)؛ HBA1C Less than 8. Exclusion major conditions: Absence in the exercise؛ Lack of supplementation in doses specified؛ Consumption Insulin.
Age
From 40 years old to 60 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 48
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

1

Registry name
000
Secondary trial Id
0000
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Pajuhesh Square, Hamedan
City
Hamedan
Postal code
Approval date
2017-01-18, 1395/10/29
Ethics committee reference number
IR.UMSHA.REC.1395.467

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
Glucagonlike Peptide -1(GLP1)
Timepoint
The first day and 8 weeks after
Method of measurement
Elisa

2

Description
Dipeptidyl Peptidase-4
Timepoint
The first day and 8 weeks after
Method of measurement
Elisa

3

Description
Insulin Resistant
Timepoint
The first day and 8 weeks after
Method of measurement
Fasting Blood Sugar*Serum Insulin /405

Secondary outcomes

1

Description
Serum Insulin
Timepoint
The first day and 8 weeks after
Method of measurement
Blood Sample

2

Description
Fasting Blood Sugar
Timepoint
The first day and 8 weeks after
Method of measurement
Elisa

Intervention groups

1

Description
Control group : This group have not any physical activity or 25-hydroxyvitamin D3 supplements
Category
Treatment - Drugs

2

Description
Aerobic exercise group : Exercise program will be include 8 weeks (3sessions in week, each session 60-75 minutes, the intensity of exercise was 60 to 80 percent of maximum heart rate).
Category
Behavior

3

Description
Aerobic exercise with 25-Hydroxy Vitamin D3 supplementation group: This group, In addition of Exercise Performance for 8 weeks (3sessions in week, each session 60-75 minutes, the intensity of exercise was 60 to 80 percent of maximum heart rate), will be receive25-Hydroxy Vitamin D3 with dose 50000 units, One tablet per week for 8 weeks
Category
Treatment - Drugs

4

Description
Supplemented groups: this group will be receive 25-Hydroxy Vitamin D3 with dose 50000 units, One tablet per week for 8 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Jesus, Son of Mary Hospital in Isfahan
Full name of responsible person
Naser Rahimi
Street address
Shams Abade Avenue, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan, Vice chancellor for research of Bu Ali Sina University
Full name of responsible person
Mohamad Ali Samavati Sharif
Street address
Vice chancellor for research, Bu Ali Sina University, Bu Ali Sina University, Pajuhesh Square, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan, Vice chancellor for research of Bu Ali Sina 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
Bu Ali Sina University, Hamedan
Full name of responsible person
Naesr Rahimi
Position
Master's, PH.D Student, Exercise Physiology
Other areas of specialty/work
Street address
School of Physical Education and Sport Sciences, Hamedan University, Pajuhesh Square, Hamedan
City
Hamedan
Postal code
Phone
+98 31 3612 2649
Fax
Email
n.rahimi2009@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bu Ali Sina University, Hamedan
Full name of responsible person
Naser Rahimi
Position
Master's, PH.D Student, Exercise Physiology
Other areas of specialty/work
Street address
School of Physical Education and Sport Sciences, Hamedan University, Pajuhesh Square, Hamedan
City
Hamedan
Postal code
Phone
+98 36122649
Fax
Email
n.rahimi2009@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bu Ali Sina University, Hamedan
Full name of responsible person
Naser Rahimi
Position
Master's, PH.D Student, Exercise Physiology
Other areas of specialty/work
Street address
School of Physical Education and Sport Sciences, Hamedan University, Pajuhesh Square, Hamedan
City
Hamedan
Postal code
Phone
+98 31 3612 2649
Fax
Email
n.rahimi2009@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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