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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.

Register:	ClinicalTrials.gov
Last refreshed on:	3 August 2015
Main ID:	NCT02254200
Date of registration:	29/09/2014
Prospective Registration:	No
Primary sponsor:	Istituto Auxologico Italiano
Public title:	Exercise Training and Fitness in Severe Obesity INTFMOBE
Scientific title:	Effect of Short-term High-intensity Interval and Fatmax Training on Aerobic and Metabolic Fitness in Obese Subjects
Date of first enrolment:	January 2013
Target sample size:	19
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02254200
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase:	N/A

Countries of recruitment
Italy

Contacts

Name:	Mauro Cornacchia, MD
Address:
Telephone:
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Affiliation:	Istituto Auxologico Italiano, Pulmonary Rehabilitation Department

Name:	Alberto Salvadori, MD
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Affiliation:	Istituto Auxologico Italiano, Pulmonary Rehabilitation Department

Name:	Paolo Fanari, MD
Address:
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Affiliation:	Istituto Auxologico Italiano, Pulmonary Rehabilitation Department

Name:	Franco Codecasa, MD
Address:
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Affiliation:	Istituto Auxologico Italiano, Pulmonary Rehabilitation Department

Name:	Stefano Lanzi, MSc
Address:
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Affiliation:	University of Lausanne, Department of Physiology

Name:	Davide Malatesta, PhD
Address:
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Affiliation:	University of Lausanne, Institute of Sport Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- BMI = 35 kg*m-2

Exclusion Criteria:

- Hypertension (blood pressure > 130/90)

- Impaired fasting glucose (> 6.1 mmol*L-1)

- Type 2 diabetes

- Abnormal ECG readings at rest

Age minimum: 20 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Obesity

Intervention(s)

Other: HIIT group

Other: Fatmax group

Primary Outcome(s)

Fat oxidation rates (FORs) [Time Frame: After two-wk-long of Fatmax or HIIT traning]

Maximal Oxygen consumption (VO2 max) [Time Frame: After two-wk-long of Fatmax or HIIT traning]

Secondary Outcome(s)

HOMA-IR [Time Frame: After two-wk-long of Fatmax or HIIT traning]

Non-esterified fatty acid (NEFA) [Time Frame: After two-wk-long of Fatmax or HIIT traning]

Insulin [Time Frame: After two-wk-long of Fatmax or HIIT traning]

Secondary ID(s)

06C301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Lausanne

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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