Sedentary Lifestyle
Conditions
Keywords
Fibroblast growth factor 21 (FGF21), Exercise, Metabolic equivalents (METs), Lipolysis, Glucose, Free fatty acids (FFAs), Epinephrine
Brief summary
We evaluated the effect of two weeks of intensive supervised physical activity in serum fibroblast growth factor 21 (FGF21) levels.
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.
Interventions
OTHERSupervised Exercising
A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks.
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks | Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks | Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise | 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 | Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise | 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 | Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise | 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 | Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise | 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 | Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise | 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 |
Countries
Mexico
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 3 |
Baseline characteristics
| Characteristic | Supervised Exercising |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants |
| Age Continuous | 24.0 years STANDARD_DEVIATION 3.7 |
| Region of Enrollment Mexico | 63 participants |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supervised Exercising | Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks | Baseline | 276.8 ng/L |
| Supervised Exercising | Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks | Final (after 2 weeks) | 460.8 ng/L |
Comparison: 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).p-value: <0.00195% CI: [0.034, 0.144]Regression, Linear
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supervised Exercising | Change From Baseline Epinephrine Acutely and at Two Weeks | Baseline | 9.2 pg/mL |
| Supervised Exercising | Change From Baseline Epinephrine Acutely and at Two Weeks | Final (at 2 weeks) | 15.5 pg/mL |
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Supervised Exercising | Change From Baseline Fasting Glucose Acutely and at Two Weeks | Baseline Glucose | 86.0 mg/dL | Standard Deviation 7.1 |
| Supervised Exercising | Change From Baseline Fasting Glucose Acutely and at Two Weeks | Final Glucose (at 2 weeks) | 86.3 mg/dL | Standard Deviation 6.4 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supervised Exercising | Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks | Baseline | 0.36 mg/dL |
| Supervised Exercising | Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks | Final (after 2 weeks) | 0.54 mg/dL |
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
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supervised Exercising | Change From Baseline Leptin Acutely and at Two Weeks | Final (at 2 weeks) | 12.4 ng/mL |
| Supervised Exercising | Change From Baseline Leptin Acutely and at Two Weeks | Baseline | 13.1 ng/mL |
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
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supervised Exercising | Change From Baseline Total Adiponectin Acutely and at Two Weeks | Baseline | 10.1 ng/mL |
| Supervised Exercising | Change From Baseline Total Adiponectin Acutely and at Two Weeks | Final (at 2 weeks) | 10.5 ng/mL |