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High-intensity Interval, Low Volume Training in Metabolic Syndrome (Intraining-MET)

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ClinicalTrials.gov Identifier: NCT03087721
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Information provided by (Responsible Party):
Jaime Gallo, Universidad de Antioquia

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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Insulin Resistance Behavioral: HIIT-LV Behavioral: CAE Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1x2 HIIT-LV, 3 times a week, 24 min 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.

Active Comparator: CAE, moderate intensity, 3 times a week, 36 min Behavioral: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Colombia
IPS-Universitaria
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Universidad de Antioquia
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Investigators
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Principal Investigator: Juan Calderón, MD, PhD Professor
Study Director: Daniel Aguirre, PhD Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jaime Gallo, MD, MSc, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT03087721     History of Changes
Other Study ID Numbers: 54-2016
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaime Gallo, Universidad de Antioquia:
Metabolic Syndrome
Exercise Training
Interval Training
Skeletal Muscle
Risk Factors
Insulin Resistance
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs