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

History of Changes

Results First Received: January 20, 2012

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label
Condition:	Sedentary Lifestyle
Intervention:	Other: Supervised Exercising

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From March 2010 to August 2011 a total of 60 sedentary young women without contraindication for exercising were included. Study was carried out at Department of Endocrinology, Cardiology and Internal Medicine of the INCMNSZ.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In the initial visit, patients were instructed to keep unaltered their diet, lifestyle and physical activity. Basal daily physical activity was evaluated with a questionnaire. All participants were assigned to the intervention group. All subjects underwent basal and final physical and biochemical evaluation.

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Supervised Exercising
STARTED	63
COMPLETED	60
NOT COMPLETED	3
Protocol Violation	3

Baseline Characteristics

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Reporting Groups

	Description
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.

Baseline Measures

	Supervised Exercising
Number of Participants [units: participants]	63
Age [units: participants]
<=18 years	0
Between 18 and 65 years	63
>=65 years	0
Age [units: years] Mean ± Standard Deviation	24.0 ± 3.7
Gender [units: participants]
Female	63
Male	0
Region of Enrollment [units: participants]
Mexico	63

Outcome Measures

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1. Primary:

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 ]

Measure Type	Primary
Measure Title	Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks
Measure Description	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.
Time Frame	Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated. All participants were analyzed.

Reporting Groups

	Description
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.

Measured Values

	Supervised Exercising
Number of Participants Analyzed [units: participants]	60
Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks [units: ng/L] Median ( Inter-Quartile Range )
Baseline	276.8 ( 142.8 to 568.6 )
Final (after 2 weeks)	460.8 ( 298.2 to 742.1 )

Statistical Analysis 1 for Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks

Groups ^[1]	Supervised Exercising
Method ^[2]	Regression, Linear
P Value ^[3]	<0.001
Slope ^[4]	0.089
Standard Error of the mean	± 0.063
95% Confidence Interval	( 0.034 to 0.144 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	FGF21 was log transformed to approximate normality before analyses. Null hypothesis was Ho = Y1 (FGF21 level at baseline) = Y2 (FGF21 level after two weeks of exercising). Power calculation was 80% with 60 participants evaluated (one group). To evaluate the effect of exercise on clinical and biochemical parameters, we used the difference between final – basal levels (“delta”).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Adjusted for age, time of exercise, creatinine, waist to hip ratio, fat percentage, body mass index, mean rest heart rate, blood pressure.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	All reported p values are based on two-sided tests considering ≤0.05 as significant.
[4]	Other relevant estimation information:
	Metabolic equivalents (METs) consumed were independently associated with the log of delta (final-basal) FGF21 levels.

2. Secondary:

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 ]

Measure Type	Secondary
Measure Title	Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks
Measure Description	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.
Time Frame	Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.

Reporting Groups

	Description
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.

Measured Values

	Supervised Exercising
Number of Participants Analyzed [units: participants]	60
Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks [units: mg/dL] Median ( Inter-Quartile Range )
Baseline	0.36 ( 0.24 to 0.44 )
Final (after 2 weeks)	0.54 ( 0.43 to 0.66 )

No statistical analysis provided for Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks

3. Secondary:

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 ]

Measure Type	Secondary
Measure Title	Change From Baseline Epinephrine Acutely and at Two Weeks
Measure Description	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.
Time Frame	Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report (5), we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.

Reporting Groups

	Description
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.

Measured Values

	Supervised Exercising
Number of Participants Analyzed [units: participants]	60
Change From Baseline Epinephrine Acutely and at Two Weeks [units: pg/mL] Median ( Inter-Quartile Range )
Baseline	9.2 ( 5.9 to 12.1 )
Final (at 2 weeks)	15.5 ( 11.3 to 18.8 )

No statistical analysis provided for Change From Baseline Epinephrine Acutely and at Two Weeks

4. Secondary:

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 ]

Measure Type	Secondary
Measure Title	Change From Baseline Leptin Acutely and at Two Weeks
Measure Description	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
Time Frame	Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.

Reporting Groups

	Description
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.

Measured Values

	Supervised Exercising
Number of Participants Analyzed [units: participants]	60
Change From Baseline Leptin Acutely and at Two Weeks [units: ng/mL] Median ( Inter-Quartile Range )
Baseline	13.1 ( 8.7 to 21.1 )
Final (at 2 weeks)	12.4 ( 10.0 to 16.2 )

No statistical analysis provided for Change From Baseline Leptin Acutely and at Two Weeks

5. Secondary:

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 ]

Measure Type	Secondary
Measure Title	Change From Baseline Total Adiponectin Acutely and at Two Weeks
Measure Description	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
Time Frame	Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.

Reporting Groups

	Description
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.

Measured Values

	Supervised Exercising
Number of Participants Analyzed [units: participants]	60
Change From Baseline Total Adiponectin Acutely and at Two Weeks [units: ng/mL] Median ( Inter-Quartile Range )
Baseline	10.1 ( 8.0 to 13.4 )
Final (at 2 weeks)	10.5 ( 8.0 to 13.2 )

No statistical analysis provided for Change From Baseline Total Adiponectin Acutely and at Two Weeks

6. Secondary:

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 ]

Measure Type	Secondary
Measure Title	Change From Baseline Fasting Glucose Acutely and at Two Weeks
Measure Description	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
Time Frame	Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.

Reporting Groups

	Description
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.

Measured Values

	Supervised Exercising
Number of Participants Analyzed [units: participants]	60
Change From Baseline Fasting Glucose Acutely and at Two Weeks [units: mg/dL] Mean ± Standard Deviation
Baseline Glucose	86.0 ± 7.1
Final Glucose (at 2 weeks)	86.3 ± 6.4

No statistical analysis provided for Change From Baseline Fasting Glucose Acutely and at Two Weeks

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We cannot fully control other potential sources of physical activity. The results may not be applicable to men. We did not register the caloric consumption during the study.

Results Point of Contact:

Name/Title: Dr. Daniel Cuevas-Ramos
Organization: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
phone: 525554870900 ext 2407
e-mail: shiverqks@hotmail.com

Publications:

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. Epub 2010 Jun 21.

Hill J, Timmis A. Exercise tolerance testing. BMJ. 2002 May 4;324(7345):1084-7. Review. No abstract available.

Publications automatically indexed to this study:

Cuevas-Ramos D, Almeda-Valdés P, Meza-Arana CE, Brito-Córdova G, Gómez-Pérez FJ, Mehta R, Oseguera-Moguel J, Aguilar-Salinas CA. Exercise increases serum fibroblast growth factor 21 (FGF21) levels. PLoS One. 2012;7(5):e38022. Epub 2012 May 31.

Responsible Party:	Daniel Cuevas-Ramos, 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

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