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
  Purpose

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


Condition Intervention
Sedentary Lifestyle
Other: Supervised Exercising

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels After a Cardiorespiratory Exercise Program

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 82
Study Start Date: March 2010
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 35 Years
Genders 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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
Additional 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
Study First Received: January 11, 2012
Results First Received: January 20, 2012
Last Updated: January 9, 2013
Health Authority: Mexico: Ethics Committee

Keywords provided by 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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014