NCT02254200

Brief Summary

Obesity is commonly associated with insulin resistance and hyperinsulinemia, which seem to be linked with an impaired ability to oxidize lipids, particularly in class III obese individuals \[Body Mass Index (BMI): \> 40 kg\*m-2\]. Exercise training is an effective strategy to improve insulin sensitivity and to reduce the risk of type 2 diabetes. This study aimed to compare the effects of two different 2-wk-long training modalities \[continuous at the intensity eliciting the maximal fat oxidation (Fatmax) versus adapted high intensity interval training (HIIT)\] on aerobic and metabolic fitness of class II and III obese men. It was hypothesized that, because of the nature of HIIT in the stimulation of rapid changes, aerobic fitness, fat oxidation rates during exercise and insulin sensitivity would be improved to a greater extent when adapted HIIT compared to Fatmax training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

September 29, 2014

Last Update Submit

July 20, 2015

Conditions

Keywords

exercisefat oxidationindirect calorimetryinsulin sensitivityweight management

Outcome Measures

Primary Outcomes (2)

  • Maximal Oxygen consumption (VO2 max)

    VO2 max at incremental test performed at the end of Fatmax or HIIT training period

    After two-wk-long of Fatmax or HIIT traning

  • Fat oxidation rates (FORs)

    FORs at incremental test performed at the end of Fatmax or HIIT training period

    After two-wk-long of Fatmax or HIIT traning

Secondary Outcomes (3)

  • HOMA-IR

    After two-wk-long of Fatmax or HIIT traning

  • Non-esterified fatty acid (NEFA)

    After two-wk-long of Fatmax or HIIT traning

  • Insulin

    After two-wk-long of Fatmax or HIIT traning

Study Arms (2)

Fatmax group

EXPERIMENTAL

Group who performed a continuous training program at the intensity eliciting the maximal fat oxidation

Other: Fatmax group

HIIT group

EXPERIMENTAL

Group who performed a continuous training program with high intensity interval

Other: HIIT group

Interventions

For the Fatmax group each session will consist of 40-50 min of continuous exercise with an intensity that corresponded to the individual Fatmax (moderate intensity)

Fatmax group

For HIIT group, each session will consist of 10x60-s cycling intervals interspersed with 60-s of recovery. The workloads will be selected to elicit a heart rate of \~90% maximal heart rate during the intervals with a pedal rate of 90-100 revolutions.min-1, whereas during recovery, the participants will be allowed to pedal against a resistance of 50 W

HIIT group

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI ≥ 35 kg\*m-2

You may not qualify if:

  • Hypertension (blood pressure \> 130/90)
  • Impaired fasting glucose (\> 6.1 mmol\*L-1)
  • Type 2 diabetes
  • Abnormal ECG readings at rest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano, Ospedale San Giuseppe

Verbania, VB, 28921, Italy

Location

Related Publications (8)

  • Houmard JA. Intramuscular lipid oxidation and obesity. Am J Physiol Regul Integr Comp Physiol. 2008 Apr;294(4):R1111-6. doi: 10.1152/ajpregu.00396.2007. Epub 2008 Feb 6.

    PMID: 18256136BACKGROUND
  • Houmard JA, Tanner CJ, Slentz CA, Duscha BD, McCartney JS, Kraus WE. Effect of the volume and intensity of exercise training on insulin sensitivity. J Appl Physiol (1985). 2004 Jan;96(1):101-6. doi: 10.1152/japplphysiol.00707.2003. Epub 2003 Sep 12.

    PMID: 12972442BACKGROUND
  • Dumortier M, Brandou F, Perez-Martin A, Fedou C, Mercier J, Brun JF. Low intensity endurance exercise targeted for lipid oxidation improves body composition and insulin sensitivity in patients with the metabolic syndrome. Diabetes Metab. 2003 Nov;29(5):509-18. doi: 10.1016/s1262-3636(07)70065-4.

    PMID: 14631328BACKGROUND
  • Bordenave S, Metz L, Flavier S, Lambert K, Ghanassia E, Dupuy AM, Michel F, Puech-Cathala AM, Raynaud E, Brun JF, Mercier J. Training-induced improvement in lipid oxidation in type 2 diabetes mellitus is related to alterations in muscle mitochondrial activity. Effect of endurance training in type 2 diabetes. Diabetes Metab. 2008 Apr;34(2):162-8. doi: 10.1016/j.diabet.2007.11.006.

    PMID: 18396088BACKGROUND
  • Burgomaster KA, Howarth KR, Phillips SM, Rakobowchuk M, Macdonald MJ, McGee SL, Gibala MJ. Similar metabolic adaptations during exercise after low volume sprint interval and traditional endurance training in humans. J Physiol. 2008 Jan 1;586(1):151-60. doi: 10.1113/jphysiol.2007.142109. Epub 2007 Nov 8.

    PMID: 17991697BACKGROUND
  • Whyte LJ, Gill JM, Cathcart AJ. Effect of 2 weeks of sprint interval training on health-related outcomes in sedentary overweight/obese men. Metabolism. 2010 Oct;59(10):1421-8. doi: 10.1016/j.metabol.2010.01.002. Epub 2010 Feb 12.

    PMID: 20153487BACKGROUND
  • Trilk JL, Singhal A, Bigelman KA, Cureton KJ. Effect of sprint interval training on circulatory function during exercise in sedentary, overweight/obese women. Eur J Appl Physiol. 2011 Aug;111(8):1591-7. doi: 10.1007/s00421-010-1777-z. Epub 2010 Dec 29.

    PMID: 21190036BACKGROUND
  • Lanzi S, Codecasa F, Cornacchia M, Maestrini S, Capodaglio P, Brunani A, Fanari P, Salvadori A, Malatesta D. Short-term HIIT and Fat max training increase aerobic and metabolic fitness in men with class II and III obesity. Obesity (Silver Spring). 2015 Oct;23(10):1987-94. doi: 10.1002/oby.21206. Epub 2015 Sep 3.

MeSH Terms

Conditions

ObesityMotor ActivityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Stefano Lanzi, MSc

    University of Lausanne, Department of Physiology

    PRINCIPAL INVESTIGATOR
  • Alberto Salvadori, MD

    Istituto Auxologico Italiano, Pulmonary Rehabilitation Department

    STUDY DIRECTOR
  • Franco Codecasa, MD

    Istituto Auxologico Italiano, Pulmonary Rehabilitation Department

    PRINCIPAL INVESTIGATOR
  • Mauro Cornacchia, MD

    Istituto Auxologico Italiano, Pulmonary Rehabilitation Department

    STUDY CHAIR
  • Davide Malatesta, PhD

    University of Lausanne, Institute of Sport Sciences

    STUDY DIRECTOR
  • Paolo Fanari, MD

    Istituto Auxologico Italiano, Pulmonary Rehabilitation Department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 1, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations