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

Sedentary Lifestyle Clinical Trial

Official title:

Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels After a Cardiorespiratory Exercise Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512368
• Other study ID #: REF173
• Secondary ID: 48024
• Status: Completed
• Phase: N/A
• First received: January 11, 2012
• Last updated: January 9, 2013
• Start date: March 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2013
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Sedentary Lifestyle

Intervention

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.

Locations

Country	Name	City	State
Mexico	INCMNSZ	Mexico City	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

Cuevas-Ramos D, Almeda-Valdes P, Gómez-Pérez FJ, Meza-Arana CE, Cruz-Bautista I, Arellano-Campos O, Navarrete-López 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. — View Citation

Hill J, Timmis A. Exercise tolerance testing. BMJ. 2002 May 4;324(7345):1084-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks	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.	Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise	No
Secondary	Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks	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.	Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise	No
Secondary	Change From Baseline Epinephrine Acutely and at Two Weeks	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.	Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise	No
Secondary	Change From Baseline Leptin Acutely and at Two Weeks	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	Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise	No
Secondary	Change From Baseline Total Adiponectin Acutely and at Two Weeks	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	Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise	No
Secondary	Change From Baseline Fasting Glucose Acutely and at Two Weeks	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	Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise	Yes

External Links

•   INCMNSZ