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

January 11, 2012
January 9, 2013
March 2010
August 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
Serum measurement of FGF21 using human ELISA kit
Complete list of historical versions of study NCT01512368 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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
  • 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 ] [ Designated as safety issue: No ]
    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
  • 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 ] [ Designated as safety issue: Yes ]
    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
  • 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 ] [ Designated as safety issue: No ]
    Serum measurement of FFAs
  • 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 ] [ Designated as safety issue: No ]
    Serum measurement of epinephrine
  • 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 ] [ Designated as safety issue: No ]
    Serum measurement of leptin
  • 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 ] [ Designated as safety issue: No ]
    Serum measurement of total adiponectin
  • Change from baseline fasting glucose and insulin 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 ] [ Designated as safety issue: Yes ]
    Serum measurement of glucose and insulin
Not Provided
Not Provided
 
Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels Correlated With Exercise
Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels After a Cardiorespiratory Exercise Program

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

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Sedentary Lifestyle
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
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.
Intervention: Other: Supervised Exercising

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
November 2011
August 2011   (final data collection date for primary outcome measure)

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)
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01512368
REF173, 48024
Yes
Daniel Cuevas-Ramos, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Not Provided
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
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP