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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03087721 |
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Date of registration:
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06/03/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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High-intensity Interval, Low Volume Training in Metabolic Syndrome
Intraining-MET |
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Scientific 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) |
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Date of first enrolment:
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March 1, 2017 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03087721 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Colombia
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Contacts
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Name:
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Daniel Aguirre, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor |
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Name:
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Juan Calderón, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Professor |
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Key inclusion & exclusion 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
Age minimum:
40 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Insulin Resistance
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Metabolic Syndrome
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Intervention(s)
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Behavioral: CAE
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Behavioral: HIIT-LV
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Primary Outcome(s)
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Insulin resistance
[Time Frame: 12-week]
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Insulin sensitivity
[Time Frame: 12-week]
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Pancreatic ß-cell function
[Time Frame: 12-week]
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Secondary Outcome(s)
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Mass muscle of right thigh
[Time Frame: 12-week]
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Glycosylated hemoglobin
[Time Frame: 12-week]
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Muscle fibre type composition of right thigh
[Time Frame: 12-week]
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Musclin
[Time Frame: 12-week]
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Apelin
[Time Frame: 12-week]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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