Single Maximal Exercise Session and the Metabolic Response of Physically Inactive Young Adults (EASY-Study)

NCT06680713 | Completed DMC

• 2 other identifiers: 2023-01SOCHED 2023-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn how the metabolic parameters of physically inactive young adults respond to a progressive exercise testing. The main questions it aims to answer are: Does a progressive exercise test induce metabolic adaptations that differ from a normal or physiologic status? Does the changes in circulating insulin might indicate metabolic dysfunctions in physically inactive young adults? Researchers will compare the metabolic status at baseline (rest) and the responses immediately after the finalization of a progressive exercise test until fatigue by collecting blood and urine samples before and after the exercise testing. Participants will: Undergo a progressive exercise test on a cycle ergometer where vital signs such as heart rate, blood pressure, rating of perceived effort, pulse and muscle oximetry will be recorded during the test. Visit the laboratory once where all procedure will be conducted there. Stay in touch for the following week in case some exercise-related symptoms develops.

Conditions

Physical Deconditioning

Keywords

Insulin; Metabolism; Exercise

Outcome Measures

Primary Outcomes (2)

• Glycemia

  Glucose in mg/dl

  Up to 2 months

• Insulinemia

  Insulin in uUI/ml

  Up to 2 months

Secondary Outcomes (11)

• Total cholesterol

  Up to 2 months

• HDL cholesterol

  Up to 2 months

• LDL cholesterol

  Up to 2 months

• VLDL cholesterol

  Up to 2 months

• Triglycerides

  Up to 2 months

Study Arms (1)

Progressive exercise test

EXPERIMENTAL

The incremental effort test will be performed. Thus, on a cycle ergometer, each participant will begin the test with a pedaling cadence of 60-70 RPM at 30W load. Every 3 minutes, this load will increase by 30W, always maintaining the same pedaling cadence. Heart rate, blood pressure, rating of perceived effort, pulse oximetry and muscle oximetry will be monitored throughout the test.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Progressive exercise testing on a cyclo ergometer

Progressive exercise test

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Physically inactive (less than 150 minutes of weekly moderate-intensity or less than 75 minutes of weekly vigorous physical activity.
• Without medical contraindication to perform physical activity

You may not qualify if:

• Consumption of drugs with anti-inflammatory and/or hypoglycemic effects during the last two weeks.

Sponsors & Collaborators

• Sergio Martinez-Huenchullan: lead
• Universidad Austral de Chile: collaborator

Study Sites (1)

Universidad San Sebastián

Valdivia, Los Ríos Region, 5090000, Chile

Location

Related Publications (10)

• Goodwin ML, Harris JE, Hernandez A, Gladden LB. Blood lactate measurements and analysis during exercise: a guide for clinicians. J Diabetes Sci Technol. 2007 Jul;1(4):558-69. doi: 10.1177/193229680700100414.

  PMID: 19885119 BACKGROUND

• Garneau L, Parsons SA, Smith SR, Mulvihill EE, Sparks LM, Aguer C. Plasma Myokine Concentrations After Acute Exercise in Non-obese and Obese Sedentary Women. Front Physiol. 2020 Feb 18;11:18. doi: 10.3389/fphys.2020.00018. eCollection 2020.

  PMID: 32132925 BACKGROUND

• Slusher AL, Whitehurst M, Zoeller RF, Mock JT, Maharaj M, Huang CJ. Attenuated fibroblast growth factor 21 response to acute aerobic exercise in obese individuals. Nutr Metab Cardiovasc Dis. 2015 Sep;25(9):839-845. doi: 10.1016/j.numecd.2015.06.002. Epub 2015 Jun 16.

  PMID: 26141939 BACKGROUND

• Sabaratnam R, Pedersen AJT, Kristensen JM, Handberg A, Wojtaszewski JFP, Hojlund K. Intact regulation of muscle expression and circulating levels of myokines in response to exercise in patients with type 2 diabetes. Physiol Rep. 2018 Jun;6(12):e13723. doi: 10.14814/phy2.13723.

  PMID: 29924476 BACKGROUND

• Ming AY, Yoo E, Vorontsov EN, Altamentova SM, Kilkenny DM, Rocheleau JV. Dynamics and Distribution of Klothobeta (KLB) and fibroblast growth factor receptor-1 (FGFR1) in living cells reveal the fibroblast growth factor-21 (FGF21)-induced receptor complex. J Biol Chem. 2012 Jun 8;287(24):19997-20006. doi: 10.1074/jbc.M111.325670. Epub 2012 Apr 20.

  PMID: 22523080 BACKGROUND

• Fisher FM, Maratos-Flier E. Understanding the Physiology of FGF21. Annu Rev Physiol. 2016;78:223-41. doi: 10.1146/annurev-physiol-021115-105339. Epub 2015 Nov 19.

  PMID: 26654352 BACKGROUND

• Laurens C, Bergouignan A, Moro C. Exercise-Released Myokines in the Control of Energy Metabolism. Front Physiol. 2020 Feb 13;11:91. doi: 10.3389/fphys.2020.00091. eCollection 2020.

  PMID: 32116795 BACKGROUND

• Quinn A, Doody C, O'Shea D. The effect of a physical activity education programme on physical activity, fitness, quality of life and attitudes to exercise in obese females. J Sci Med Sport. 2008 Sep;11(5):469-72. doi: 10.1016/j.jsams.2007.07.011. Epub 2007 Sep 14.

  PMID: 17869182 BACKGROUND

• Pedersen BK. The diseasome of physical inactivity--and the role of myokines in muscle--fat cross talk. J Physiol. 2009 Dec 1;587(Pt 23):5559-68. doi: 10.1113/jphysiol.2009.179515. Epub 2009 Sep 14.

  PMID: 19752112 BACKGROUND

• Gadde KM, Martin CK, Berthoud HR, Heymsfield SB. Obesity: Pathophysiology and Management. J Am Coll Cardiol. 2018 Jan 2;71(1):69-84. doi: 10.1016/j.jacc.2017.11.011.

  PMID: 29301630 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sergio F Martinez-Huenchullan, PhD

  Universidad San Sebastián

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 8, 2024
• Study Start: June 18, 2024
• Primary Completion: July 17, 2024
• Study Completion: July 31, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 30-10-2024 to 30-10-2026
• Access Criteria: Data will be shared by contacting the principal investigator at sergio.martinez@uss.cl

Locations

CL (1)