Back to resultsHIT in Insulin-resistant and Insulin-sensitive Obese Adolescents
Primary Purpose
Obesity, Insulin-resistant, Adolescents
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Group Insulin-Resistant
Group Insulin-Sensitive
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Insulin-resistant, Adolescents, High-intensity interval training
Eligibility Criteria
Criteria
Inclusion Criteria:
- aged 12-16 years
- with a body mass index z-score (zBMI) ≥ + 2SD
- puberty stage > 3
- the boys and girls had to present a minimum physical fitness, according to the International Physical Activity Questionnaire (IPAQ), according to the activity performed during the last week and confirmed this using the peak cardiopulmonary test (VO2).
Exclusion Criteria:
- individuals undergoing drug treatment for weight control;
- indiviudals who had cardiac, orthopedic, respiratory or renal problems, diabetes, uncontrolled hypertension, genetic syndrome or hormonal abnormalities.
Sites / Locations
- Santa Casa of Sao Paulo School
- Emef Angelina Maffei Vita
- Emef Plinio Queroz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group Insulin-resistant
Group Insulin-sensitive
Arm Description
Insulin-resistant obese adolescents
Insulin-sensitive obese adolescents
Outcomes
Primary Outcome Measures
rate of Peak oxygen consumption (VOpeak)
The cardiopulmonary test protocol for determination the VOpeak (ml/kg/min) included running on a treadmill (Model ATL, Inbrasport Ltda; Brazil) at a speed of 4 km/h with 1 km/h increments every minute until the participant showed exhaustion.
We evaluated ventilatory parameters on a gas analyzer (model VO2000; Inbrasport Ltda; Brazil).
rate of Intensity at first ventilatory anaerobic threshold (VAT1)
The cardiopulmonary test protocol included running on a treadmill (Model ATL, Inbrasport Ltda; Brazil) at a speed of 4 km/h with 1 km/h increments every minute until the participant showed exhaustion.
We evaluated ventilatory parameters on a gas analyzer (model VO2000; Inbrasport Ltda; Brazil).We determined VAT1 (ml/kg/min) using the V-slope method of Beaver et al.
rate of Peak Heart rate
The cardiopulmonary test protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil). speed of 4 km / h with increments of 1 km / h every minute until the participant shows exhaustion.
rate of carbohydrate oxidation
The substrate oxidation pattern protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil),during continuous exercise of submaximal intensity (45 minutes of treadmill running at the intensity of the first ventilatory anaerobic threshold).
rate of lipid oxidation
The substrate oxidation pattern protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil),during continuous exercise of submaximal intensity (45 minutes of treadmill running at the intensity of the first ventilatory anaerobic threshold).
Secondary Outcome Measures
Full Information
NCT ID
NCT03042234
First Posted
January 30, 2017
Last Updated
July 11, 2021
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03042234
Brief Title
HIT in Insulin-resistant and Insulin-sensitive Obese Adolescents
Official Title
Effects of High-intensity Interval Training on Cardiorespiratory Performance and Substrate Oxidation in Insulin-resistant and Insulin-sensitive Obese Adolescents: A Before-and-after Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 8, 2017 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
November 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluate the effects of HIT on the cardiorespiratory performance and substrate oxidation of insulin-resistant and insulin-sensitive obese adolescents.
Detailed Description
Objective: To evaluate the effect of high-intensity interval training (HIT) on the cardiorespiratory performance and substrate oxidation pattern in insulin-resistant and insulin-sensitive obese adolescents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin-resistant, Adolescents
Keywords
Obesity, Insulin-resistant, Adolescents, High-intensity interval training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Insulin-resistant
Arm Type
Experimental
Arm Description
Insulin-resistant obese adolescents
Arm Title
Group Insulin-sensitive
Arm Type
Experimental
Arm Description
Insulin-sensitive obese adolescents
Intervention Type
Other
Intervention Name(s)
Group Insulin-Resistant
Other Intervention Name(s)
Insulin-resistant obese adolescents
Intervention Description
High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
Intervention Type
Other
Intervention Name(s)
Group Insulin-Sensitive
Other Intervention Name(s)
Insulin-sensitive obese adolescents
Intervention Description
High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
Primary Outcome Measure Information:
Title
rate of Peak oxygen consumption (VOpeak)
Description
The cardiopulmonary test protocol for determination the VOpeak (ml/kg/min) included running on a treadmill (Model ATL, Inbrasport Ltda; Brazil) at a speed of 4 km/h with 1 km/h increments every minute until the participant showed exhaustion.
We evaluated ventilatory parameters on a gas analyzer (model VO2000; Inbrasport Ltda; Brazil).
Time Frame
4 weeks
Title
rate of Intensity at first ventilatory anaerobic threshold (VAT1)
Description
The cardiopulmonary test protocol included running on a treadmill (Model ATL, Inbrasport Ltda; Brazil) at a speed of 4 km/h with 1 km/h increments every minute until the participant showed exhaustion.
We evaluated ventilatory parameters on a gas analyzer (model VO2000; Inbrasport Ltda; Brazil).We determined VAT1 (ml/kg/min) using the V-slope method of Beaver et al.
Time Frame
4 weeks
Title
rate of Peak Heart rate
Description
The cardiopulmonary test protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil). speed of 4 km / h with increments of 1 km / h every minute until the participant shows exhaustion.
Time Frame
4 weeks
Title
rate of carbohydrate oxidation
Description
The substrate oxidation pattern protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil),during continuous exercise of submaximal intensity (45 minutes of treadmill running at the intensity of the first ventilatory anaerobic threshold).
Time Frame
4 weeks
Title
rate of lipid oxidation
Description
The substrate oxidation pattern protocol included treadmill running (Model ATL, Inbrasport Ltda; Brazil),during continuous exercise of submaximal intensity (45 minutes of treadmill running at the intensity of the first ventilatory anaerobic threshold).
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Criteria
Inclusion Criteria:
aged 12-16 years
with a body mass index z-score (zBMI) ≥ + 2SD
puberty stage > 3
the boys and girls had to present a minimum physical fitness, according to the International Physical Activity Questionnaire (IPAQ), according to the activity performed during the last week and confirmed this using the peak cardiopulmonary test (VO2).
Exclusion Criteria:
individuals undergoing drug treatment for weight control;
indiviudals who had cardiac, orthopedic, respiratory or renal problems, diabetes, uncontrolled hypertension, genetic syndrome or hormonal abnormalities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana Monique Lino Aparecido
Organizational Affiliation
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Casa of Sao Paulo School
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Emef Angelina Maffei Vita
City
Sao Paulo
ZIP/Postal Code
02545-000
Country
Brazil
Facility Name
Emef Plinio Queroz
City
São Paulo
ZIP/Postal Code
08341-080
Country
Brazil
12. IPD Sharing Statement
Citations:
Citation
ROSSETTI, MB; BRITO, RR; NORTON, RC. Prevenção primária de doenças cardiovasculares na obesidade infatojuvenil: efeito anti-inflamatório do exercício físico. Rev Bras Med Esporte. 2009
Results Reference
background
PubMed Identifier
22880097
Citation
Corte de Araujo AC, Roschel H, Picanco AR, do Prado DM, Villares SM, de Sa Pinto AL, Gualano B. Similar health benefits of endurance and high-intensity interval training in obese children. PLoS One. 2012;7(8):e42747. doi: 10.1371/journal.pone.0042747. Epub 2012 Aug 6.
Results Reference
background
Citation
KLOSTER, R & LIBERALI, R. Emagrecimento: composição da dieta e exercício físico. Rev Bras Nutr Esportiva. 2012 set-out; 11(2):288-306
Results Reference
background
Citation
FOUREAUX, G; PINTO, KMC; DÂMASO, A. Efeito do consumo excessivo de oxigênio após exercício e da taxa metabólica de repouso no gasto energético. Rev Bras Med Esporte. 2006 nov-dez; 12(6):393-398.
Results Reference
background
Citation
AMERICAN COLLEGE OF SPORTS MEDICINE - ACSM. ACSM's Guidelines for Exercise Testing and Prescription. 8ª edição. Baltimore: Williams & Wilkins, 2009.
Results Reference
background
PubMed Identifier
19002708
Citation
Aucouturier J, Rance M, Meyer M, Isacco L, Thivel D, Fellmann N, Duclos M, Duche P. Determination of the maximal fat oxidation point in obese children and adolescents: validity of methods to assess maximal aerobic power. Eur J Appl Physiol. 2009 Jan;105(2):325-31. doi: 10.1007/s00421-008-0907-3. Epub 2008 Nov 12.
Results Reference
background
Citation
MARQUEZI, ML. Adaptações decorrentes do exercício cardiorrespiratório sobre a oxidação de lipídeos: exercício aeróbio. Rev Mackenzie de Educação Física e Esporte. 2010; 9(1):32-35.
Results Reference
background
PubMed Identifier
11782653
Citation
Achten J, Gleeson M, Jeukendrup AE. Determination of the exercise intensity that elicits maximal fat oxidation. Med Sci Sports Exerc. 2002 Jan;34(1):92-7. doi: 10.1097/00005768-200201000-00015.
Results Reference
background
PubMed Identifier
14750010
Citation
Achten J, Jeukendrup AE. Relation between plasma lactate concentration and fat oxidation rates over a wide range of exercise intensities. Int J Sports Med. 2004 Jan;25(1):32-7. doi: 10.1055/s-2003-45231.
Results Reference
background
Citation
MARQUEZI, ML; DUARTE, L; SCHWARTZ, J; SOUSA, PCR. Variabilidade interindividual da oxidação de substratos durante o exercício. Rev Mackenzie de Educação Física e Esporte. 2009; 8(1): 3-19.
Results Reference
background
PubMed Identifier
19855335
Citation
Carey DG. Quantifying differences in the "fat burning" zone and the aerobic zone: implications for training. J Strength Cond Res. 2009 Oct;23(7):2090-5. doi: 10.1519/JSC.0b013e3181bac5c5.
Results Reference
background
PubMed Identifier
15133003
Citation
Braun B, Sharoff C, Chipkin SR, Beaudoin F. Effects of insulin resistance on substrate utilization during exercise in overweight women. J Appl Physiol (1985). 2004 Sep;97(3):991-7. doi: 10.1152/japplphysiol.00231.2004. Epub 2004 May 7.
Results Reference
background
PubMed Identifier
11118013
Citation
Blaak EE, van Aggel-Leijssen DP, Wagenmakers AJ, Saris WH, van Baak MA. Impaired oxidation of plasma-derived fatty acids in type 2 diabetic subjects during moderate-intensity exercise. Diabetes. 2000 Dec;49(12):2102-7. doi: 10.2337/diabetes.49.12.2102.
Results Reference
background
PubMed Identifier
12444908
Citation
Borghouts LB, Wagenmakers AJ, Goyens PL, Keizer HA. Substrate utilization in non-obese Type II diabetic patients at rest and during exercise. Clin Sci (Lond). 2002 Dec;103(6):559-66. doi: 10.1042/cs1030559.
Results Reference
background
PubMed Identifier
11547220
Citation
Perez-Martin A, Dumortier M, Raynaud E, Brun JF, Fedou C, Bringer J, Mercier J. Balance of substrate oxidation during submaximal exercise in lean and obese people. Diabetes Metab. 2001 Sep;27(4 Pt 1):466-74.
Results Reference
background
PubMed Identifier
22289907
Citation
Gibala MJ, Little JP, Macdonald MJ, Hawley JA. Physiological adaptations to low-volume, high-intensity interval training in health and disease. J Physiol. 2012 Mar 1;590(5):1077-84. doi: 10.1113/jphysiol.2011.224725. Epub 2012 Jan 30.
Results Reference
background
PubMed Identifier
19127177
Citation
Donnelly JE, Blair SN, Jakicic JM, Manore MM, Rankin JW, Smith BK; American College of Sports Medicine. American College of Sports Medicine Position Stand. Appropriate physical activity intervention strategies for weight loss and prevention of weight regain for adults. Med Sci Sports Exerc. 2009 Feb;41(2):459-71. doi: 10.1249/MSS.0b013e3181949333. Erratum In: Med Sci Sports Exerc. 2009 Jul;41(7):1532.
Results Reference
background
PubMed Identifier
17991697
Citation
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.
Results Reference
background
PubMed Identifier
20484014
Citation
Talanian JL, Holloway GP, Snook LA, Heigenhauser GJ, Bonen A, Spriet LL. Exercise training increases sarcolemmal and mitochondrial fatty acid transport proteins in human skeletal muscle. Am J Physiol Endocrinol Metab. 2010 Aug;299(2):E180-8. doi: 10.1152/ajpendo.00073.2010. Epub 2010 May 18.
Results Reference
background
PubMed Identifier
18606913
Citation
Tjonna AE, Lee SJ, Rognmo O, Stolen TO, Bye A, Haram PM, Loennechen JP, Al-Share QY, Skogvoll E, Slordahl SA, Kemi OJ, Najjar SM, Wisloff U. Aerobic interval training versus continuous moderate exercise as a treatment for the metabolic syndrome: a pilot study. Circulation. 2008 Jul 22;118(4):346-54. doi: 10.1161/CIRCULATIONAHA.108.772822. Epub 2008 Jul 7.
Results Reference
background
PubMed Identifier
17170203
Citation
Talanian JL, Galloway SD, Heigenhauser GJ, Bonen A, Spriet LL. Two weeks of high-intensity aerobic interval training increases the capacity for fat oxidation during exercise in women. J Appl Physiol (1985). 2007 Apr;102(4):1439-47. doi: 10.1152/japplphysiol.01098.2006. Epub 2006 Dec 14.
Results Reference
background
PubMed Identifier
19088769
Citation
Perry CG, Heigenhauser GJ, Bonen A, Spriet LL. High-intensity aerobic interval training increases fat and carbohydrate metabolic capacities in human skeletal muscle. Appl Physiol Nutr Metab. 2008 Dec;33(6):1112-23. doi: 10.1139/H08-097.
Results Reference
background
PubMed Identifier
20100740
Citation
Little JP, Safdar A, Wilkin GP, Tarnopolsky MA, Gibala MJ. A practical model of low-volume high-intensity interval training induces mitochondrial biogenesis in human skeletal muscle: potential mechanisms. J Physiol. 2010 Mar 15;588(Pt 6):1011-22. doi: 10.1113/jphysiol.2009.181743. Epub 2010 Jan 25.
Results Reference
background
PubMed Identifier
21451146
Citation
Little JP, Safdar A, Bishop D, Tarnopolsky MA, Gibala MJ. An acute bout of high-intensity interval training increases the nuclear abundance of PGC-1alpha and activates mitochondrial biogenesis in human skeletal muscle. Am J Physiol Regul Integr Comp Physiol. 2011 Jun;300(6):R1303-10. doi: 10.1152/ajpregu.00538.2010. Epub 2011 Mar 30.
Results Reference
background
PubMed Identifier
20440122
Citation
Baquet G, Gamelin FX, Mucci P, Thevenet D, Van Praagh E, Berthoin S. Continuous vs. interval aerobic training in 8- to 11-year-old children. J Strength Cond Res. 2010 May;24(5):1381-8. doi: 10.1519/JSC.0b013e3181d1575a.
Results Reference
background
PubMed Identifier
18026621
Citation
de Onis M, Onyango AW, Borghi E, Siyam A, Nishida C, Siekmann J. Development of a WHO growth reference for school-aged children and adolescents. Bull World Health Organ. 2007 Sep;85(9):660-7. doi: 10.2471/blt.07.043497.
Results Reference
background
Citation
TANNER JM. Growth at adolescence. Oxford: Blackwell Scientific Pub; 1962.
Results Reference
background
Citation
MATSUDO, SM; ARAÚJO, TL; MATSUDO, VKR; ANDRADE, DR; ANDRADE, EL; OLIVEIRA, LC; et al. Questionário Internacional de Atividade Física (IPAQ): estudo de validade e reprodutibilidade no Brasil. Rev Bras Ativ Saude. 2001;10:5-18.
Results Reference
background
PubMed Identifier
17982531
Citation
Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.
Results Reference
background
PubMed Identifier
7174412
Citation
Caiozzo VJ, Davis JA, Ellis JF, Azus JL, Vandagriff R, Prietto CA, McMaster WC. A comparison of gas exchange indices used to detect the anaerobic threshold. J Appl Physiol Respir Environ Exerc Physiol. 1982 Nov;53(5):1184-9. doi: 10.1152/jappl.1982.53.5.1184.
Results Reference
background
PubMed Identifier
14232808
Citation
WASSERMAN K, MCILROY MB. DETECTING THE THRESHOLD OF ANAEROBIC METABOLISM IN CARDIAC PATIENTS DURING EXERCISE. Am J Cardiol. 1964 Dec;14:844-52. doi: 10.1016/0002-9149(64)90012-8. No abstract available.
Results Reference
background
PubMed Identifier
4001567
Citation
Bhambhani Y, Singh M. Ventilatory thresholds during a graded exercise test. Respiration. 1985;47(2):120-8. doi: 10.1159/000194758.
Results Reference
background
PubMed Identifier
21944864
Citation
Gmada N, Marzouki H, Haboubi M, Tabka Z, Shephard RJ, Bouhlel E. Crossover and maximal fat-oxidation points in sedentary healthy subjects: methodological issues. Diabetes Metab. 2012 Feb;38(1):40-5. doi: 10.1016/j.diabet.2011.07.004. Epub 2011 Sep 25.
Results Reference
background
PubMed Identifier
19568198
Citation
Cheneviere X, Malatesta D, Peters EM, Borrani F. A mathematical model to describe fat oxidation kinetics during graded exercise. Med Sci Sports Exerc. 2009 Aug;41(8):1615-25. doi: 10.1249/MSS.0b013e31819e2f91.
Results Reference
background
PubMed Identifier
24523934
Citation
Lanzi S, Codecasa F, Cornacchia M, Maestrini S, Salvadori A, Brunani A, Malatesta D. Fat oxidation, hormonal and plasma metabolite kinetics during a submaximal incremental test in lean and obese adults. PLoS One. 2014 Feb 11;9(2):e88707. doi: 10.1371/journal.pone.0088707. eCollection 2014.
Results Reference
background
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HIT in Insulin-resistant and Insulin-sensitive Obese Adolescents
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