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High-intensity Interval, Low Volume Training in Metabolic Syndrome

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03087721
Acronym
Intraining-MET
Enrollment
60
Registered
2017-03-22
Start date
2017-03-01
Completion date
2019-07-31
Last updated
2019-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Metabolic Syndrome

Keywords

Metabolic Syndrome, Exercise Training, Interval Training, Skeletal Muscle, Risk Factors, Insulin Resistance

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.

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).

Interventions

BEHAVIORALHIIT-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.

BEHAVIORALCAE

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.

Sponsors

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
CollaboratorOTHER_GOV
Universidad de Antioquia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Insulin sensitivity12-weekUsing HOMA model (units as percentages of a normal reference population)
Insulin resistance12-weekUsing HOMA model (arbitrary units)
Pancreatic β-cell function12-weekUsing HOMA model (units as percentages of a normal reference population)

Secondary

MeasureTime frameDescription
Musclin12-weekUsing plasma levels of musclin (pg/mL)
Glycosylated hemoglobin12-weekUsing blood tests (%)
Apelin12-weekUsing plasma levels of apelin (pg/mL)
Mass muscle of right thigh12-weekUsing dual energy x-ray absorptiometry (DEXA) (kg/m2)
Muscle fibre type composition of right thigh12-weekUsing carnosine quantification by hydrogen magnetic resonance spectroscopy (1H-MRS) (% fibre type I)

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026