NCT01323088

Brief Summary

In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise versus resistance exercise) without calorie restriction on total and regional adiposity, ectopic fat in the liver and skeletal muscle, and risk of type 2 diabetes in overweight girls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

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

August 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

2.2 years

First QC Date

March 22, 2011

Last Update Submit

April 12, 2013

Conditions

Abdominal ObesityPhysical Activity

Keywords

Childhood obesityVisceral fatInsulin resistanceLiver fatSkeletal muscle lipidRegular exercise

Outcome Measures

Primary Outcomes (1)

  • Abdominal obesity, visceral fat

    3 month

Secondary Outcomes (1)

  • insulin sensitivity by a 3-hour hyperinsulinemic-euglycemic clamp, oral glucose tolerance test, liver fat and intramyocellular lipid by 1H-magnetic resonance spectroscopy.

    3 month

Study Arms (3)

Control

OTHER

Standard care control (no-exercise)

Other: Control

Aerobic Exercise

ACTIVE COMPARATOR
Other: Aerobic exercise

Resistance Exercise

ACTIVE COMPARATOR
Other: Resistance Exercise

Interventions

ControlOTHER

Standard care control (no exercise)

Control
Resistance ExerciseOTHER

Supervised resistance exercise using stack weight equipments.

Resistance Exercise
Aerobic exerciseOTHER

Supervised aerobic exercise using treadmills, bikes, and ellipticals

Aerobic Exercise

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy overweight (BMI \>-95th) youth between 12 and 18 years of age
  • Waist circumference \>-75th percentile
  • Sedentary (no structured exercise \>2 times/week for past 6 months)
  • Non-smokers, non-diabetic, no medical conditions
  • Weight stable for past 3 months

You may not qualify if:

  • Smokers
  • Diabetes
  • Psychiatric disorders
  • Syndromic obesity
  • Pregnancy
  • Taking medications known to affect study outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

Location

Related Publications (3)

  • Yu WW, Lee S, Arslanian S, Tamim H, Kuk JL. Effects of Exercise on Resting Metabolic Rate in Adolescents with Overweight and Obesity. Child Obes. 2021 Jun;17(4):249-256. doi: 10.1089/chi.2020.0280. Epub 2021 Mar 18.

    PMID: 33739874DERIVED

  • Kuk JL, Lee S. Assessing the utility of cardiorespiratory fitness, visceral fat, and liver fat in predicting changes in insulin sensitivity beyond simple changes in body weight after exercise training in adolescents. Appl Physiol Nutr Metab. 2021 Jan;46(1):55-62. doi: 10.1139/apnm-2020-0284. Epub 2020 Jul 16.

    PMID: 32674604DERIVED

  • Kuk JL, Lee S. Sex and Ethnic Differences in the Relationship between Changes in Anthropometric Measurements and Visceral Fat in Adolescents with Obesity. J Pediatr. 2019 Oct;213:121-127. doi: 10.1016/j.jpeds.2019.05.052. Epub 2019 Jun 22.

    PMID: 31235380DERIVED

MeSH Terms

Conditions

Obesity, AbdominalMotor ActivityPediatric ObesityInsulin ResistanceFatty Liver

Interventions

Resistance TrainingExercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • SoJung Lee, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

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

March 22, 2011

First Posted

March 25, 2011

Study Start

August 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 15, 2013

Record last verified: 2013-04

Locations

US(1)