Clinical trial NCT01512368: Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels Correlated With Exercise
Official title: Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels After a Cardiorespiratory Exercise Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Fibroblast growth factor 21 (FGF21)
Exercise
Metabolic equivalents (METs)
Lipolysis
Glucose
Free fatty acids (FFAs)
Epinephrine
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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

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.

Eligibility 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)

Primary outcomes:
measure: Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks
timeFrame: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise
Secondary outcomes:
measure: Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks
timeFrame: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise
measure: Change From Baseline Epinephrine Acutely and at Two Weeks
timeFrame: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise
measure: Change From Baseline Leptin Acutely and at Two Weeks
timeFrame: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise
measure: Change From Baseline Total Adiponectin Acutely and at Two Weeks
timeFrame: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise
measure: Change From Baseline Fasting Glucose Acutely and at Two Weeks
timeFrame: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: INCMNSZ
state: Tlalpan
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Daniel Cuevas-Ramos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Paloma Almeda-Valdes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Carlos A Aguilar-Salinas, MD
role: STUDY_DIRECTOR
References:
citation: Cuevas-Ramos D, Almeda-Valdes P, Gomez-Perez FJ, Meza-Arana CE, Cruz-Bautista I, Arellano-Campos O, Navarrete-Lopez M, Aguilar-Salinas CA. Daily physical activity, fasting glucose, uric acid, and body mass index are independent factors associated with serum fibroblast growth factor 21 levels. Eur J Endocrinol. 2010 Sep;163(3):469-77. doi: 10.1530/EJE-10-0454. Epub 2010 Jun 21.
citation: Hill J, Timmis A. Exercise tolerance testing. BMJ. 2002 May 4;324(7345):1084-7. doi: 10.1136/bmj.324.7345.1084. No abstract available.
citation: Cuevas-Ramos D, Almeda-Valdes P, Meza-Arana CE, Brito-Cordova G, Gomez-Perez FJ, Mehta R, Oseguera-Moguel J, Aguilar-Salinas CA. Exercise increases serum fibroblast growth factor 21 (FGF21) levels. PLoS One. 2012;7(5):e38022. doi: 10.1371/journal.pone.0038022. Epub 2012 May 31.