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Completed

NCT Number: NCT03087721

High-intensity Interval, Low Volume Training in Metabolic Syndrome

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IPS-Universitaria

Medellín, Antioquia, Colombia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIIT-LV

Behavioral

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.

CAE

Behavioral

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.

Primary outcomes

  1. Insulin sensitivity

    Time frame: 12-week

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

  2. Insulin resistance

    Time frame: 12-week

    Using HOMA model (arbitrary units)

  3. Pancreatic β-cell function

    Time frame: 12-week

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

Secondary outcomes

  1. Glycosylated hemoglobin

    Time frame: 12-week

    Using blood tests (%)

  2. Mass muscle of right thigh

    Time frame: 12-week

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

  3. Muscle fibre type composition of right thigh

    Time frame: 12-week

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

  4. Musclin

    Time frame: 12-week

    Using plasma levels of musclin (pg/mL)

  5. Apelin

    Time frame: 12-week

    Using plasma levels of apelin (pg/mL)

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Collaborators

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

Registry information

Official study 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)

Acronym: Intraining-MET

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2017
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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