NCT03087721

Brief Summary

The primary objective of the study is to compare the efficacy of an intervention with high-intensity interval, low volume training (HIIT-LV) or continuous aerobic exercise (CAE) on insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function in adults with metabolic syndrome (MS). The secondary objective is to compare the efficacy of an intervention with HIIT-LV or CAE on glycosylated hemoglobin, mass and muscle fibre type composition of right thigh and plasma levels of musclin and apelin in adults with MS. The investigators hypothesized that HIIT-LV is more effective in decreasing insulin resistance and glycosylated hemoglobin and plasma concentrations of musclin and increasing plasma concentrations of apelin, and both mass and muscle fibre type I percentage in thigh, than CAE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

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, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

2.4 years

First QC Date

March 6, 2017

Last Update Submit

July 31, 2019

Conditions

Metabolic SyndromeInsulin Resistance

Keywords

Metabolic SyndromeExercise TrainingInterval TrainingSkeletal MuscleRisk FactorsInsulin Resistance

Outcome Measures

Primary Outcomes (3)

  • Insulin sensitivity

    Using HOMA model (units as percentages of a normal reference population)

    12-week

  • Insulin resistance

    Using HOMA model (arbitrary units)

    12-week

  • Pancreatic β-cell function

    Using HOMA model (units as percentages of a normal reference population)

    12-week

Secondary Outcomes (5)

  • Glycosylated hemoglobin

    12-week

  • Mass muscle of right thigh

    12-week

  • Muscle fibre type composition of right thigh

    12-week

  • Musclin

    12-week

  • Apelin

    12-week

Study Arms (2)

1x2 HIIT-LV, 3 times a week, 24 min

EXPERIMENTAL
Behavioral: HIIT-LV

CAE, moderate intensity, 3 times a week, 36 min

ACTIVE COMPARATOR
Behavioral: CAE

Interventions

HIIT-LVBEHAVIORAL

Supervised endurance treadmill training as walking/running "uphill", 3 times/week during 12 weeks starting at 85-90% of previously determined maximum oxygen consumption (VO2 max). Warm-up 3 min at 30% of VO2 max, 3 min cool-down. Progression in intensity every 3erd week.

1x2 HIIT-LV, 3 times a week, 24 min
CAEBEHAVIORAL

Supervised moderate intensity treadmill training, 3 times/week for 12 weeks starting at 70% of VO2 max. Warm-up 3 min at 30% of VO2 max, 3 min cool-down. Progression in intensity every 3erd week.

CAE, moderate intensity, 3 times a week, 36 min

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Metabolic syndrome defined according to the International Diabetes Federation-criteria.
  • Insulin resistance defined according to the HOMA greater than 2.25
  • Sedentary lifestyle (less than 60 min of physical activity per week)

You may not qualify if:

  • Vegetarian diet
  • Vitamin D3 supplementation
  • Oral contraceptives
  • Musculoskeletal diseases or injuries
  • Physical, sensory or cognitive impairment
  • History of cardiovascular disease (coronary, cerebrovascular, peripheral arterial disease, uncontrolled cardiac arrhythmias).
  • Pulmonary diseases
  • Acute or chronic inflammatory conditions
  • Cancer
  • Human immunodeficiency virus infection
  • Diabetes mellitus
  • Hyperthyroidism
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IPS-Universitaria

Medellín, Antioquia, Colombia

Location

Related Publications (4)

  • Gallo-Villegas J, Restrepo D, Perez L, Castro-Valencia LA, Narvaez-Sanchez R, Osorio J, Aguirre-Acevedo DC, Calderon JC. Safety of High-Intensity, Low-Volume Interval Training or Continuous Aerobic Training in Adults With Metabolic Syndrome. J Patient Saf. 2022 Jun 1;18(4):295-301. doi: 10.1097/PTS.0000000000000922. Epub 2021 Sep 20.

    PMID: 34870388DERIVED

  • Aristizabal JC, Montoya E, Sanchez YL, Yepes-Calderon M, Narvaez-Sanchez R, Gallo-Villegas JA, Calderon JC. Effects of Low-Volume, High-Intensity Interval Training Compared with Continuous Training on Regional and Global Body Composition in Adults with Metabolic Syndrome: A post hoc Analysis of a Randomized Clinical Trial. Ann Nutr Metab. 2021;77(5):279-288. doi: 10.1159/000518909. Epub 2021 Oct 6.

    PMID: 34763335DERIVED

  • Gallo-Villegas J, Castro-Valencia LA, Perez L, Restrepo D, Guerrero O, Cardona S, Sanchez YL, Yepes-Calderon M, Valbuena LH, Pena M, Milan AF, Trillos-Almanza MC, Granados S, Aristizabal JC, Estrada-Castrillon M, Narvaez-Sanchez R, Osorio J, Aguirre-Acevedo DC, Calderon JC. Efficacy of high-intensity interval- or continuous aerobic-training on insulin resistance and muscle function in adults with metabolic syndrome: a clinical trial. Eur J Appl Physiol. 2022 Feb;122(2):331-344. doi: 10.1007/s00421-021-04835-w. Epub 2021 Oct 23.

    PMID: 34687360DERIVED

  • Gallo-Villegas J, Aristizabal JC, Estrada M, Valbuena LH, Narvaez-Sanchez R, Osorio J, Aguirre-Acevedo DC, Calderon JC. Efficacy of high-intensity, low-volume interval training compared to continuous aerobic training on insulin resistance, skeletal muscle structure and function in adults with metabolic syndrome: study protocol for a randomized controlled clinical trial (Intraining-MET). Trials. 2018 Feb 27;19(1):144. doi: 10.1186/s13063-018-2541-7.

    PMID: 29482601DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Juan Calderón, MD, PhD

    Professor

    PRINCIPAL INVESTIGATOR

  • Daniel Aguirre, PhD

    Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 22, 2017

Study Start

March 1, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

August 1, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

Locations

CO(1)