High-intensity Interval, Low Volume Training in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— Intraining-MET  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087721
• Other study ID #: 54-2016
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: July 2019
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Colombia	IPS-Universitaria	Medellin	Antioquia

Sponsors (2)

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

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	Using HOMA model (units as percentages of a normal reference population)	12-week
Primary	Insulin resistance	Using HOMA model (arbitrary units)	12-week
Primary	Pancreatic ß-cell function	Using HOMA model (units as percentages of a normal reference population)	12-week
Secondary	Glycosylated hemoglobin	Using blood tests (%)	12-week
Secondary	Mass muscle of right thigh	Using dual energy x-ray absorptiometry (DEXA) (kg/m2)	12-week
Secondary	Muscle fibre type composition of right thigh	Using carnosine quantification by hydrogen magnetic resonance spectroscopy (1H-MRS) (% fibre type I)	12-week
Secondary	Musclin	Using plasma levels of musclin (pg/mL)	12-week
Secondary	Apelin	Using plasma levels of apelin (pg/mL)	12-week