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

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ClinicalTrials.gov Identifier: NCT01512368
Recruitment Status : Completed
First Posted : January 19, 2012
Results First Posted : March 26, 2012
Last Update Posted : January 14, 2013
Sponsor:
Information provided by (Responsible Party):
Daniel Cuevas-Ramos, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary:
We evaluated the effect of two weeks of intensive supervised physical activity in serum fibroblast growth factor 21 (FGF21) levels.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Other: Supervised Exercising Not Applicable

Detailed Description:
Comparative and longitudinal study. Anthropometric and biochemical evaluation were done before, 1hr and 4hr after a bout of exercise and repeated after two weeks of daily supervised exercise. We studied sedentary young healthy women. A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks. The Department of Endocrinology and Metabolism at the INCMNSZ performed all biochemical laboratory measurements using standardized procedures.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels After a Cardiorespiratory Exercise Program
Study Start Date : March 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Other: Supervised Exercising
A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks.
Other Name: Bruce's protocol



Primary Outcome Measures :
  1. 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 ]
    Serum measurement of FGF21 using human ELISA kit was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.


Secondary Outcome Measures :
  1. 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 ]
    Serum measurement of free fatty acids (FFAs) was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.

  2. 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 ]
    Serum measurement of epinephrine was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.

  3. 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 ]
    Serum measurement of leptin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise

  4. 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 ]
    Serum measurement of total adiponectin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise

  5. 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 ]
    Serum measurement of glucose was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women
  • Aged 18 to 35 years old,
  • Body mass index (BMI) <30 kg/m2
  • Without contraindication for exercising

Exclusion Criteria:

  • Metabolic syndrome
  • Diabetes
  • Dyslipidemia
  • Hypertension
  • Asthma
  • Thyroid disease
  • Treated with fibrates, beta agonists or blockers
  • History or current arrhythmias, murmurs, cardiomegaly, or treatment for cardiovascular diseases -
  • Contraindications for exercise testing were also considered as exclusion criteria (see references)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512368


Locations
Mexico
INCMNSZ
Mexico City, Tlalpan, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Principal Investigator: Daniel Cuevas-Ramos, MD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Principal Investigator: Paloma Almeda-Valdes, MD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Director: Carlos A Aguilar-Salinas, MD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Cuevas-Ramos, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01512368     History of Changes
Other Study ID Numbers: REF173
48024 ( Other Grant/Funding Number: Consejo Nacional de Ciencia y Tecnología (CONACYT)/216324 )
First Posted: January 19, 2012    Key Record Dates
Results First Posted: March 26, 2012
Last Update Posted: January 14, 2013
Last Verified: January 2013

Keywords provided by Daniel Cuevas-Ramos, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Fibroblast growth factor 21 (FGF21)
Exercise
Metabolic equivalents (METs)
Lipolysis
Glucose
Free fatty acids (FFAs)
Epinephrine

Additional relevant MeSH terms:
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action