Sedentary LifestyleNCT01512368

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

A study testing Supervised Exercising in people with Sedentary Lifestyle, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Sedentary Lifestyle
What is being tested?: Supervised Exercising
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteMexico
Study dates: Mar 2010to Nov 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Women
Aged 18 to 35 years old,
Body mass index (BMI) <30 kg/m2
Without contraindication for exercising

Who cannot join

Metabolic syndrome
Diabetes
Dyslipidemia
Hypertension
Asthma
Thyroid disease

Show all 9Show fewer

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)

Trial locations and contacts

1 site in 1 country.

Mexico1 site

INCMNSZ
Mexico City, Tlalpan, 14000

Other trials in Mexico

About this study

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

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

Read the 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.

Conditions: Sedentary Lifestyle
Being tested: Supervised Exercising
Keywords: Fibroblast growth factor 21 (FGF21), Exercise, Metabolic equivalents (METs), Lipolysis, Glucose, Free fatty acids (FFAs), Epinephrine
Medical subject headings: Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Supervised ExercisingOther
Also called Bruce's protocol
A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks.

Study groups in NCT01512368
Study group	Role	What they receive
Supervised exercising	Experimental	A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants. Receives: Other: Supervised Exercising

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Nov 2011

First posted19 Jan 2012 (estimated)
Study startMar 2010
Primary completionAug 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01512368
Sponsor's protocol ID: REF173
Other IDs: 48024
Status last verified: Jan 2013
First submitted: 11 Jan 2012
Last updated: 14 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Cuevas-Ramos D, Almeda-Valdes P, Gomez-Perez FJ, Meza-Arana CE, Cruz-Bautista I, Arellano-Campos O, Navarrete-Lopez 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.
PubMed 20566587
Hill J, Timmis A. Exercise tolerance testing. BMJ. 2002 May 4;324(7345):1084-7. doi: 10.1136/bmj.324.7345.1084. No abstract available.
PubMed 11991917
Cuevas-Ramos D, Almeda-Valdes P, Meza-Arana CE, Brito-Cordova G, Gomez-Perez FJ, Mehta R, Oseguera-Moguel J, Aguilar-Salinas CA. Exercise increases serum fibroblast growth factor 21 (FGF21) levels. PLoS One. 2012;7(5):e38022. doi: 10.1371/journal.pone.0038022. Epub 2012 May 31.
PubMed 22701542

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity

All Sedentary Lifestyle trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels After a Cardiorespiratory Exercise Program
ClinicalTrials.gov ID: NCT01512368
Acronym / sponsor ID: REF173
Conditions: Sedentary Lifestyle
Keywords: Fibroblast growth factor 21 (FGF21), Exercise, Metabolic equivalents (METs), Lipolysis, Glucose, Free fatty acids (FFAs), Epinephrine
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
Study start: Mar 2010
Primary completion: Aug 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 19 Jan 2012 (estimated)
Results: Posted 26 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Supervised exercising	Experimental	Other: Supervised ExercisingA treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Women
Aged 18 to 35 years old,
Body mass index (BMI) <30 kg/m2
Without contraindication for exercising

Key exclusion criteria (9 listed)

Metabolic syndrome
Diabetes
Dyslipidemia
Hypertension
Asthma

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Supervised ExercisingAlso: Bruce's protocolA treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks.	Other	Supervised exercising

Primary outcome

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
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.

5 secondary outcomes

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
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
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
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
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

Results and safety

Results posted to the registry on 26 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Supervised Exercising	63	60

Primary outcome: 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. Median (Inter-Quartile Range). Unit: ng/L

Measure	Supervised Exercising n = 60
Baseline	276.8 (142.8 to 568.6)
Final (after 2 weeks)	460.8 (298.2 to 742.1)

Supervised Exercising: Slope: 0.089 (95% CI 0.034 to 0.144), p <0.001, Regression, Linear

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were supervised throughout every treadmill test.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Supervised Exercising	0 of 60 (0%)	0 of 60 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20566587Cuevas-Ramos D, Almeda-Valdes P, Gomez-Perez FJ, Meza-Arana CE, Cruz-Bautista I, Arellano-Campos O, Navarrete-Lopez 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.
Background: PubMed 11991917Hill J, Timmis A. Exercise tolerance testing. BMJ. 2002 May 4;324(7345):1084-7. doi: 10.1136/bmj.324.7345.1084. No abstract available.
Derived from this study: PubMed 22701542Cuevas-Ramos D, Almeda-Valdes P, Meza-Arana CE, Brito-Cordova G, Gomez-Perez FJ, Mehta R, Oseguera-Moguel J, Aguilar-Salinas CA. Exercise increases serum fibroblast growth factor 21 (FGF21) levels. PLoS One. 2012;7(5):e38022. doi: 10.1371/journal.pone.0038022. Epub 2012 May 31.
INCMNSZLink provided by the sponsor.

Related trials for Sedentary Lifestyle

Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel Cuevas-Ramos, MD principal investigator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Paloma Almeda-Valdes, MD principal investigator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Carlos A Aguilar-Salinas, MD study director

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Supervised Exercising in people with Sedentary Lifestyle, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01512368, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2013.