High-intensity Interval, Low Volume Training in Metabolic Syndrome (Intraining-MET)
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|ClinicalTrials.gov Identifier: NCT03087721|
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : December 4, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Insulin Resistance||Behavioral: HIIT-LV Behavioral: CAE||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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)|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||February 28, 2019|
|Estimated Study Completion Date :||May 31, 2019|
|Experimental: 1x2 HIIT-LV, 3 times a week, 24 min||
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||
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.
- Insulin sensitivity [ Time Frame: 12-week ]Using HOMA model (units as percentages of a normal reference population)
- Insulin resistance [ Time Frame: 12-week ]Using HOMA model (arbitrary units)
- Pancreatic β-cell function [ Time Frame: 12-week ]Using HOMA model (units as percentages of a normal reference population)
- Glycosylated hemoglobin [ Time Frame: 12-week ]Using blood tests (%)
- Mass muscle of right thigh [ Time Frame: 12-week ]Using dual energy x-ray absorptiometry (DEXA) (kg/m2)
- Muscle fibre type composition of right thigh [ Time Frame: 12-week ]Using carnosine quantification by hydrogen magnetic resonance spectroscopy (1H-MRS) (% fibre type I)
- Musclin [ Time Frame: 12-week ]Using plasma levels of musclin (pg/mL)
- Apelin [ Time Frame: 12-week ]Using plasma levels of apelin (pg/mL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087721
|Contact: Jaime Gallo, MD, MScfirstname.lastname@example.org|
|Medellin, Antioquia, Colombia|
|Contact: Jaime Gallo, MD, MSc +5742196060 email@example.com|
|Principal Investigator:||Juan Calderón, MD, PhD||Professor|
|Study Director:||Daniel Aguirre, PhD||Professor|