Abdominal ObesityNCT00739180
Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes
A study testing Resistance Exercise and Aerobic exercise in people with Abdominal Obesity, run by University of Pittsburgh at 1 site in United States.
Trial 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, and risk of type 2 diabetes in overweight children and adolescents. Read more about this study
- Who is it for?
- Ages 12 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- Resistance Exercise and Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Oct 2011
- 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 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Smokers,
- diabetic,
- psychiatric disorders,
- syndromatic obesity
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
About this study
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, and risk of type 2 diabetes in overweight children and adolescents.
- Conditions
- Abdominal Obesity
- Being tested
- Control, Resistance Exercise, Aerobic exercise
- Keywords
- Childhood obesity, Abdominal obesity, Visceral fat, Insulin resistance, Liver fat, Skeletal muscle lipid, Fitness
- Medical subject headings
- Obesity, Abdominal, Pediatric Obesity, Insulin Resistance, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Standard care control (no exercise)
Resistance ExerciseOther
Supervised resistance exercise using stack weight equipments.
Aerobic exerciseOther
Supervised aerobic exercise using treadmills, bikes, and ellipticals
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Standard care control Receives: Other: Control |
| Aerobic Exercise | Active comparator | Not described Receives: Other: Aerobic exercise |
| Resistance Exercise | Active comparator | Not described Receives: Other: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal obesity, visceral fat
Measured: 3 month
Secondary outcomes (1)
Insulin sensitivity and secretion, glucose tolerance
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, SoJung Lee, University of Pittsburgh
- Investigators
- SoJung Lee, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739180
- Sponsor's protocol ID
- 7-08-JF-27
- Status last verified
- Oct 2012
- First submitted
- 20 Aug 2008
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33739874Kuk 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.
PubMed 32674604Kuk 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.
PubMed 31235380
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00739180
- Acronym / sponsor ID
- 7-08-JF-27
- Conditions
- Abdominal Obesity
- Keywords
- Childhood obesity, Abdominal obesity, Visceral fat, Insulin resistance, Liver fat, Skeletal muscle lipid, Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Nov 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 21 Aug 2008 (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.
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, and risk of type 2 diabetes in overweight children and adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ControlStandard care control |
| Aerobic Exercise | Active comparator | Other: Aerobic exercise |
| Resistance Exercise | Active comparator | Other: Resistance Exercise |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Smokers,
- diabetic,
- psychiatric disorders,
- syndromatic obesity
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 |
|---|---|---|
| ControlStandard care control (no exercise) | Other | Control |
| Resistance ExerciseSupervised resistance exercise using stack weight equipments. | Other | Resistance Exercise |
| Aerobic exerciseSupervised aerobic exercise using treadmills, bikes, and ellipticals | Other | Aerobic Exercise |
Primary outcome
Abdominal obesity, visceral fat
Time frame: 3 month
1 secondary outcome
Insulin sensitivity and secretion, glucose tolerance
Time frame: 3 month
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 6 Nov 2012.
- Derived from this study: PubMed 33739874Yu 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.
- Derived from this study: PubMed 32674604Kuk 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.
- Derived from this study: PubMed 31235380Kuk 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.
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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.
SoJung Lee, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise and Aerobic exercise in people with Abdominal Obesity, run by University of Pittsburgh at 1 site in United States.
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 5 inclusion and 4 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 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Abdominal obesity, visceral fat (time frame: 3 month). 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 NCT00739180, which also lists 3 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 6 Nov 2012.