High-intensity Interval, Low Volume Training in Metabolic Syndrome (Intraining-MET)

July 31, 2019 updated by: Jaime Gallo, Universidad de Antioquia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

60

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

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • IPS-Universitaria

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

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1x2 HIIT-LV, 3 times a week, 24 min
Behavioral: HIIT-LV
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.
Active Comparator: CAE, moderate intensity, 3 times a week, 36 min
Behavioral: CAE
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: 12-week
Using HOMA model (units as percentages of a normal reference population)
12-week
Insulin resistance
Time Frame: 12-week
Using HOMA model (arbitrary units)
12-week
Pancreatic β-cell function
Time Frame: 12-week
Using HOMA model (units as percentages of a normal reference population)
12-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated hemoglobin
Time Frame: 12-week
Using blood tests (%)
12-week
Mass muscle of right thigh
Time Frame: 12-week
Using dual energy x-ray absorptiometry (DEXA) (kg/m2)
12-week
Muscle fibre type composition of right thigh
Time Frame: 12-week
Using carnosine quantification by hydrogen magnetic resonance spectroscopy (1H-MRS) (% fibre type I)
12-week
Musclin
Time Frame: 12-week
Using plasma levels of musclin (pg/mL)
12-week
Apelin
Time Frame: 12-week
Using plasma levels of apelin (pg/mL)
12-week

Collaborators and Investigators

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

Sponsor

Universidad de Antioquia

Collaborators

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Investigators

  • Principal Investigator: Juan Calderón, MD, PhD, Professor
  • Study Director: Daniel Aguirre, PhD, Professor

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

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 (Actual)

March 1, 2017

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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