NCT01512368

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

January 11, 2012

Results QC Date

January 20, 2012

Last Update Submit

January 9, 2013

Conditions

Keywords

Fibroblast growth factor 21 (FGF21)ExerciseMetabolic equivalents (METs)LipolysisGlucoseFree fatty acids (FFAs)Epinephrine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

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.

Other: Supervised Exercising

Interventions

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

Also known as: Bruce's protocol
Supervised exercising

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INCMNSZ

Mexico City, Tlalpan, 14000, Mexico

Location

Related Publications (3)

  • 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.

    PMID: 20566587BACKGROUND
  • 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.

    PMID: 11991917BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

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

Title
Dr. Daniel Cuevas-Ramos
Organization
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Officials

  • Daniel Cuevas-Ramos, MD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR
  • Paloma Almeda-Valdes, MD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR
  • Carlos A Aguilar-Salinas, MD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 19, 2012

Study Start

March 1, 2010

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

January 14, 2013

Results First Posted

March 26, 2012

Record last verified: 2013-01

Locations