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Metabolic SyndromeIntraining-METNCT03087721

High-intensity Interval, Low Volume Training in Metabolic Syndrome

A study testing HIIT-LV and CAE in people with Metabolic Syndrome and Insulin Resistance, run by Universidad de Antioquia at 1 site in Colombia.

Completed

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

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Metabolic Syndrome, Insulin Resistance
What is being tested?
HIIT-LV and CAE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteColombia
Study dates
1 Mar 2017to 31 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

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 40 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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).
Show all 13Show fewer
  • Pulmonary diseases
  • Acute or chronic inflammatory conditions
  • Cancer
  • Human immunodeficiency virus infection
  • Diabetes mellitus
  • Hyperthyroidism
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • IPS-Universitaria

    Medellín, Antioquia

Other trials in Colombia

About this study

Official title: Efficacy of High-intensity Interval, Low-volume Training Compared to Continuous Aerobic Exercise on Insulin Resistance, Skeletal Muscle Composition and Endocrine Function in Adults With Metabolic Syndrome: a Randomized Controlled Clinical Trial (Intraining-MET)

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.

Read the detailed description

This study is a randomized, controlled, masked (single blind, outcomes assessor) clinical trial, with allocation by the minimization method, with two parallel groups and intention of superiority. It was designed to test the hypothesis that a 12-week program of HIIT-LV, yields larger beneficial effects on insulin resistance, skeletal muscle composition and endocrine function than CAE.

Although aerobic exercise increases cardio-respiratory capacity, modifies risk factors and decreases mortality risk, there is currently controversy and gaps in knowledge over the efficacy of more intense and low-volume physical activities on muscle metabolism in patients with metabolic disorders.

The primary outcome will be the insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function. The secondary outcomes will be the glycosylated hemoglobin, mass and muscle fibre type composition of thigh and plasma levels of musclin and apelin. Assessments will be made before and after the 12-week program. Calculations based on previously results (difference mean 10% and SD 15%) suggest that a total number of 60 patients randomized 1:1 (30 in each group) to the two intervention groups is sufficient to detect larger beneficial effects with HIIT-LV with a p-value of 0.05 (two-sided test) and statistical power of 0.80 (primary endpoint is insulin sensitivity).

Being tested
HIIT-LV, CAE
Keywords
Metabolic Syndrome, Exercise Training, Interval Training, Skeletal Muscle, Risk Factors, Insulin Resistance
Medical subject headings
Metabolic Syndrome, Insulin Resistance

What participants receive

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

  • HIIT-LVBehavioural

    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.

  • CAEBehavioural

    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.

Study groups in NCT03087721
Study groupRoleWhat they receive
1x2 HIIT-LV, 3 times a week, 24 minExperimentalNot described
Receives: Behavioral: HIIT-LV
CAE, moderate intensity, 3 times a week, 36 minActive comparatorNot described
Receives: Behavioral: CAE

What is being measured

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

  1. Insulin sensitivity

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

    Measured: 12-week

  2. Insulin resistance

    Using HOMA model (arbitrary units)

    Measured: 12-week

  3. Pancreatic β-cell function

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

    Measured: 12-week

Secondary outcomes (5)

  1. Glycosylated hemoglobin

    Using blood tests (%)

    Measured: 12-week

  2. Mass muscle of right thigh

    Using dual energy x-ray absorptiometry (DEXA) (kg/m2)

    Measured: 12-week

  3. Muscle fibre type composition of right thigh

    Using carnosine quantification by hydrogen magnetic resonance spectroscopy (1H-MRS) (% fibre type I)

    Measured: 12-week

  4. Musclin

    Using plasma levels of musclin (pg/mL)

    Measured: 12-week

  5. Apelin

    Using plasma levels of apelin (pg/mL)

    Measured: 12-week

Timeline

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

  1. First posted22 Mar 2017
  2. Study start1 Mar 2017
  3. Primary completion31 Jul 2019
  4. Study completion31 Jul 2019

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03087721
Sponsor's protocol ID
54-2016
Acronym
Intraining-MET
Status last verified
Jul 2019
First submitted
6 Mar 2017
Last updated
1 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 34870388

  • 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.

    PubMed 34763335

  • 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.

    PubMed 34687360

  • 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.

    PubMed 29482601

Questions about this trial

What is this clinical trial studying?

A study testing HIIT-LV and CAE in people with Metabolic Syndrome and Insulin Resistance, run by Universidad de Antioquia at 1 site in Colombia.

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 3 inclusion and 13 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 1 Aug 2019. 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 Colombia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Insulin sensitivity (time frame: 12-week). The study lists 3 primary outcomes in all. 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 NCT03087721, which also lists 4 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 1 Aug 2019.

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