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

January 9, 2013 updated by: Daniel Cuevas-Ramos, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Tlalpan
      • Mexico City, Tlalpan, Mexico, 14000
        • INCMNSZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 exclusion criteria (see references)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Supervised Exercising
A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks.
Other Names:
  • Bruce's protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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
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
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
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
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
Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Principal Investigator: 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
  • Study Director: Carlos A Aguilar-Salinas, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 13, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Estimate)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 9, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REF173
  • 48024 (Other Grant/Funding Number: Consejo Nacional de Ciencia y Tecnología (CONACYT)/216324)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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