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Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels Correlated With Exercise

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Cuevas-Ramos, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01512368
First received: January 11, 2012
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
Results First Received: January 20, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Sedentary Lifestyle
Intervention: Other: Supervised Exercising

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From March 2010 to August 2011 a total of 60 sedentary young women without contraindication for exercising were included. Study was carried out at Department of Endocrinology, Cardiology and Internal Medicine of the INCMNSZ.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In the initial visit, patients were instructed to keep unaltered their diet, lifestyle and physical activity. Basal daily physical activity was evaluated with a questionnaire. All participants were assigned to the intervention group. All subjects underwent basal and final physical and biochemical evaluation.

Reporting Groups
  Description
Supervised Exercising A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.

Participant Flow:   Overall Study
    Supervised Exercising  
STARTED     63  
COMPLETED     60  
NOT COMPLETED     3  
Protocol Violation                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Supervised Exercising A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.

Baseline Measures
    Supervised Exercising  
Number of Participants  
[units: participants]
 		  63  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     63  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  24.0  ± 3.7  
Gender  
[units: participants]
 		 
Female     63  
Male     0  
Region of Enrollment  
[units: participants]
 		 
Mexico     63  



  Outcome Measures
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1.  Primary:   Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks   [ Time Frame: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise ]
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2.  Secondary:   Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks   [ Time Frame: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline Epinephrine Acutely and at Two Weeks   [ Time Frame: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline Leptin Acutely and at Two Weeks   [ Time Frame: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline Total Adiponectin Acutely and at Two Weeks   [ Time Frame: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline Fasting Glucose Acutely and at Two Weeks   [ Time Frame: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We cannot fully control other potential sources of physical activity. The results may not be applicable to men. We did not register the caloric consumption during the study.  


Results Point of Contact:  
Name/Title: Dr. Daniel Cuevas-Ramos
Organization: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
phone: 525554870900 ext 2407
e-mail: shiverqks@hotmail.com


Publications:

Publications automatically indexed to this study:


Responsible Party: Daniel Cuevas-Ramos, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01512368     History of Changes
Other Study ID Numbers: REF173, 48024
Study First Received: January 11, 2012
Results First Received: January 20, 2012
Last Updated: January 9, 2013
Health Authority: Mexico: Ethics Committee