High-intensity Interval, Low Volume Training in Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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).

Official Title
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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)

Conditions
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Metabolic Syndrome, Insulin Resistance

Intervention / Treatment
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* Behavioral: HIIT-LV
* Behavioral: CAE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrome, Exercise Training, Interval Training, Skeletal Muscle, Risk Factors, Insulin Resistance