ObesityNCT03042234

HIT in Insulin-resistant and Insulin-sensitive Obese Adolescents

A study testing Group Insulin-Resistant and Group Insulin-Sensitive in people with Obesity and Insulin-resistant, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 3 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluate the effects of HIT on the cardiorespiratory performance and substrate oxidation of insulin-resistant and insulin-sensitive obese adolescents. Read more about this study

Who is it for?: Ages 12 to 16 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Insulin-resistant, Adolescents
What is being tested?: Group Insulin-Resistant and Group Insulin-Sensitive
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 3 sitesBrazil
Study dates: 8 Jul 2017to 2 Nov 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 16 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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).

Who cannot join

individuals undergoing drug treatment for weight control;
indiviudals who had cardiac, orthopedic, respiratory or renal problems, diabetes, uncontrolled hypertension, genetic syndrome or hormonal abnormalities.

Trial locations and contacts

3 sites in 1 country.

Brazil3 sites

Santa Casa of Sao Paulo School
São Paulo, 01221-020
Emef Angelina Maffei Vita
São Paulo, 02545-000
Emef Plinio Queroz
São Paulo, 08341-080

Other trials in Brazil

About this study

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

Evaluate the effects of HIT on the cardiorespiratory performance and substrate oxidation of insulin-resistant and insulin-sensitive obese adolescents.

Read the 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.

Conditions: Obesity, Insulin-resistant, Adolescents
Being tested: Group Insulin-Resistant, Group Insulin-Sensitive
Keywords: Obesity, Insulin-resistant, Adolescents, High-intensity interval training
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group Insulin-ResistantOther
Also called Insulin-resistant obese adolescents
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.
Group Insulin-SensitiveOther
Also called Insulin-sensitive obese adolescents
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.

Study groups in NCT03042234
Study group	Role	What they receive
Group Insulin-resistant	Experimental	Insulin-resistant obese adolescents Receives: Other: Group Insulin-Resistant; Other: Group Insulin-Sensitive
Group Insulin-sensitive	Experimental	Insulin-sensitive obese adolescents Receives: Other: Group Insulin-Resistant; Other: Group Insulin-Sensitive

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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).
Measured: 4 weeks
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).
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 20172 Nov 2018

First posted3 Feb 2017 (estimated)
Study start8 Jul 2017
Primary completion30 Aug 2017
Study completion2 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (35)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03042234
Sponsor's protocol ID: japarecido
Other IDs: 34634414.5.0000.5479, 1.227.250
Status last verified: Jul 2021
First submitted: 30 Jan 2017
Last updated: 15 Jul 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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
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.
PubMed 22880097
KLOSTER, R & LIBERALI, R. Emagrecimento: composição da dieta e exercício físico. Rev Bras Nutr Esportiva. 2012 set-out; 11(2):288-306
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.
AMERICAN COLLEGE OF SPORTS MEDICINE - ACSM. ACSM's Guidelines for Exercise Testing and Prescription. 8ª edição. Baltimore: Williams & Wilkins, 2009.
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.
PubMed 19002708
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.
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.
PubMed 11782653
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.
PubMed 14750010
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.
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.
PubMed 19855335
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.
PubMed 15133003
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.
PubMed 11118013
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.
PubMed 12444908
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.
PubMed 11547220

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03042234
Acronym / sponsor ID: japarecido
Conditions: Obesity, Insulin-resistant, Adolescents
Keywords: Obesity, Insulin-resistant, Adolescents, High-intensity interval training
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
Study start: 8 Jul 2017 (actual)
Primary completion: 30 Aug 2017 (actual)
Study completion: 2 Nov 2018 (actual)
First posted: 3 Feb 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate the effects of HIT on the cardiorespiratory performance and substrate oxidation of insulin-resistant and insulin-sensitive obese adolescents.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group Insulin-resistant	Experimental	Other: Group Insulin-Resistant, Other: Group Insulin-SensitiveInsulin-resistant obese adolescents
Group Insulin-sensitive	Experimental	Other: Group Insulin-Resistant, Other: Group Insulin-SensitiveInsulin-sensitive obese adolescents

Who may qualify

Ages: 12 to 16 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (2 listed)

individuals undergoing drug treatment for weight control;
indiviudals who had cardiac, orthopedic, respiratory or renal problems, diabetes, uncontrolled hypertension, genetic syndrome or hormonal abnormalities.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Group Insulin-ResistantAlso: Insulin-resistant obese adolescentsHigh 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.	Other	Group Insulin-resistant, Group Insulin-sensitive
Group Insulin-SensitiveAlso: Insulin-sensitive obese adolescentsHigh 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.	Other	Group Insulin-resistant, Group Insulin-sensitive

Primary outcome

rate of Peak oxygen consumption (VOpeak)
Time frame: 4 weeks
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)
Time frame: 4 weeks
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
Time frame: 4 weeks
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
Time frame: 4 weeks
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
Time frame: 4 weeks
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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
BackgroundROSSETTI, MB; BRITO, RR; NORTON, RC. Prevenção primária de doenças cardiovasculares na obesidade infatojuvenil: efeito anti-inflamatório do exercício físico. Rev Bras Med Esporte. 2009
Background: PubMed 22880097Corte 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.
BackgroundKLOSTER, R & LIBERALI, R. Emagrecimento: composição da dieta e exercício físico. Rev Bras Nutr Esportiva. 2012 set-out; 11(2):288-306
BackgroundFOUREAUX, 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.
BackgroundAMERICAN COLLEGE OF SPORTS MEDICINE - ACSM. ACSM's Guidelines for Exercise Testing and Prescription. 8ª edição. Baltimore: Williams & Wilkins, 2009.
Background: PubMed 19002708Aucouturier 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.
BackgroundMARQUEZI, 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.
Background: PubMed 11782653Achten 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.
Background: PubMed 14750010Achten 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.
BackgroundMARQUEZI, 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.
Background: PubMed 19855335Carey 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.
Background: PubMed 15133003Braun 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Juliana Monique Lino Aparecido principal investigator

Faculdade de Ciências Médicas da Santa Casa de São Paulo

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of Peak oxygen consumption (VOpeak) (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03042234, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.