Trial Outcomes & Findings for Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels Correlated With Exercise (NCT NCT01512368)

NCT ID: NCT01512368

Last Updated: 2013-01-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

82 participants

Primary outcome timeframe

Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise

Results posted on

2013-01-14

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	63
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Protocol Violation	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supervised Exercising n=63 Participants A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	24.0 years STANDARD_DEVIATION 3.7 • n=99 Participants
Sex: Female, Male Female	63 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment Mexico	63 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Supervised Exercising n=60 Participants A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks Baseline	276.8 ng/L Interval 142.8 to 568.6
Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks Final (after 2 weeks)	460.8 ng/L Interval 298.2 to 742.1

SECONDARY outcome

Timeframe: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Supervised Exercising n=60 Participants A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks Baseline	0.36 mg/dL Interval 0.24 to 0.44
Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks Final (after 2 weeks)	0.54 mg/dL Interval 0.43 to 0.66

SECONDARY outcome

Timeframe: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Supervised Exercising n=60 Participants A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
Change From Baseline Epinephrine Acutely and at Two Weeks Baseline	9.2 pg/mL Interval 5.9 to 12.1
Change From Baseline Epinephrine Acutely and at Two Weeks Final (at 2 weeks)	15.5 pg/mL Interval 11.3 to 18.8

SECONDARY outcome

Timeframe: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise

Population: 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.

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

Outcome measures

Outcome measures
Measure	Supervised Exercising n=60 Participants A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
Change From Baseline Leptin Acutely and at Two Weeks Baseline	13.1 ng/mL Interval 8.7 to 21.1
Change From Baseline Leptin Acutely and at Two Weeks Final (at 2 weeks)	12.4 ng/mL Interval 10.0 to 16.2

SECONDARY outcome

Timeframe: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise

Population: 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.

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

Outcome measures

Outcome measures
Measure	Supervised Exercising n=60 Participants A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
Change From Baseline Total Adiponectin Acutely and at Two Weeks Baseline	10.1 ng/mL Interval 8.0 to 13.4
Change From Baseline Total Adiponectin Acutely and at Two Weeks Final (at 2 weeks)	10.5 ng/mL Interval 8.0 to 13.2

SECONDARY outcome

Timeframe: Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise

Population: 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.

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

Outcome measures

Outcome measures
Measure	Supervised Exercising n=60 Participants A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
Change From Baseline Fasting Glucose Acutely and at Two Weeks Baseline Glucose	86.0 mg/dL Standard Deviation 7.1
Change From Baseline Fasting Glucose Acutely and at Two Weeks Final Glucose (at 2 weeks)	86.3 mg/dL Standard Deviation 6.4

Adverse Events

Supervised Exercising

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Cuevas-Ramos

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Phone: 525554870900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place