NCT03042234

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

January 30, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

July 8, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2018

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

January 30, 2017

Last Update Submit

July 11, 2021

Conditions

Keywords

ObesityInsulin-resistantAdolescentsHigh-intensity interval training

Outcome Measures

Primary Outcomes (5)

  • 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).

    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.

    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.

    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).

    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).

    4 weeks

Study Arms (2)

Group Insulin-resistant

EXPERIMENTAL

Insulin-resistant obese adolescents

Other: Group Insulin-ResistantOther: Group Insulin-Sensitive

Group Insulin-sensitive

EXPERIMENTAL

Insulin-sensitive obese adolescents

Other: Group Insulin-ResistantOther: Group Insulin-Sensitive

Interventions

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.

Also known as: Insulin-resistant obese adolescents
Group Insulin-resistantGroup Insulin-sensitive

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.

Also known as: Insulin-sensitive obese adolescents
Group Insulin-resistantGroup Insulin-sensitive

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Santa Casa of Sao Paulo School

São Paulo, 01221-020, Brazil

Location

Emef Angelina Maffei Vita

São Paulo, 02545-000, Brazil

Location

Emef Plinio Queroz

São Paulo, 08341-080, Brazil

Location

Related Publications (35)

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Juliana Monique Lino Aparecido

    Faculdade de Ciências Médicas da Santa Casa de São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator Juliana Monique Lino Aparecido

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 3, 2017

Study Start

July 8, 2017

Primary Completion

August 30, 2017

Study Completion

November 2, 2018

Last Updated

July 15, 2021

Record last verified: 2021-07

Locations