Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels Correlated With Exercise
This study has been completed.
Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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
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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
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 May 19, 2013