ExerciseNCT00998855
Glucose and Lipid Metabolism in Adolescents
An observational study of Exercise and Obesity, run by National Institutes of Health (NIH) at 1 site in United States.
Trial summary
A 12 wk aerobic exercise program will reduce visceral, hepatic and intramyocellular fat accumulation and improve insulin sensitivity and glucose metabolism in obese sedentary Hispanic adolescents. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Obesity, Insulin Sensitivity
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Dec 2011
- Phase
- Observational
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Sedentary, post pubertal, Hispanic lean and obese adolescents
Who may be able to join
- Healthy
- No medication
- Sedentary
- No first degree relative with diabetes,
- Hispanic
- BMI >30 or <25 kg/m2.
Who cannot join
- Any medication including birth control pills
- Performing more than >45 min of moderate to light physical activity/week
- Chronic illness
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Agneta L Sunehag, M.D., Ph.D, 713-798-6725, asunehag@bcm.tmc.edu
Agneta L Sunehag, M.D., Ph.D
About this study
A 12 wk aerobic exercise program will reduce visceral, hepatic and intramyocellular fat accumulation and improve insulin sensitivity and glucose metabolism in obese sedentary Hispanic adolescents.
Read the detailed description
Lean and Obese post pubertal adolescents perform an aerobic exercise program 30 minx4/week at a heart rate corresponding to at least 70% of that obtained at VO2 peak. The exercise program is preceded and followed by a 7 d diet delivered by the metabolic research kitchen (identical on both study occasions); metabolic studies (identical on both study occasions) including 24h calorimetry, measurements of glucose and lipid metabolism and insulin sensitivity and secretion using compounds labelled with stable i.e. non radioactive isotopes and gas chromatography-mass spectrometry.Fat mass and lean body mass are measured by DXA and visceral/subcutaneous, hepatic and intramyocellular fat by MRI/MRS. Since we want to specifically determine the effects of exercise, there is no intent of weight loss. The subjects are weighed twice a week to assure weight stability.
- Conditions
- Exercise, Obesity, Insulin Sensitivity
- Being tested
- Exercise
- Keywords
- Exercise in obesity
- Medical subject headings
- Motor Activity, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
12 wk aerobic or/ resistance exercise program
| Study group | Role | What they receive |
|---|---|---|
| Adolescents | Post pubertal, sedentary lean and obese Hispanic adolescents Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat distribution, insulin sensitivity, glucose production, gluconeogenesis, glycogenolysis
Measured: In response to a 12 wk exercise program.
Secondary outcomes (1)
Lipolysis, blood lipids, adiponectin, leptin and CRP
Measured: In response to a 12 wk exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startFeb 2004
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health (NIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Agneta L Sunehag, M.D., Ph.D, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998855
- Sponsor's protocol ID
- sunehagexercise
- Other IDs
- NIHNICHDRO1 HD044609
- Status last verified
- Oct 2009
- First submitted
- 20 Oct 2009
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose and Lipid Metabolism in Adolescents
- ClinicalTrials.gov ID
- NCT00998855
- Acronym / sponsor ID
- sunehagexercise
- Conditions
- Exercise, Obesity, Insulin Sensitivity
- Keywords
- Exercise in obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- National Institutes of Health (NIH)US National Institutes of Health
- Study start
- Feb 2004
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 21 Oct 2009 (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.
A 12 wk aerobic exercise program will reduce visceral, hepatic and intramyocellular fat accumulation and improve insulin sensitivity and glucose metabolism in obese sedentary Hispanic adolescents.
Detailed description
Lean and Obese post pubertal adolescents perform an aerobic exercise program 30 minx4/week at a heart rate corresponding to at least 70% of that obtained at VO2 peak. The exercise program is preceded and followed by a 7 d diet delivered by the metabolic research kitchen (identical on both study occasions); metabolic studies (identical on both study occasions) including 24h calorimetry, measurements of glucose and lipid metabolism and insulin sensitivity and secretion using compounds labelled with stable i.e. non radioactive isotopes and gas chromatography-mass spectrometry.Fat mass and lean body mass are measured by DXA and visceral/subcutaneous, hepatic and intramyocellular fat by MRI/MRS. Since we want to specifically determine the effects of exercise, there is no intent of weight loss. The subjects are weighed twice a week to assure weight stability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | Behavioral: ExercisePost pubertal, sedentary lean and obese Hispanic adolescents |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Sedentary, post pubertal, Hispanic lean and obese adolescents
Key inclusion criteria (6 listed)
- Healthy
- No medication
- Sedentary
- No first degree relative with diabetes,
- Hispanic
Key exclusion criteria (3 listed)
- Any medication including birth control pills
- Performing more than >45 min of moderate to light physical activity/week
- Chronic illness
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 |
|---|---|---|
| Exercise12 wk aerobic or/ resistance exercise program | Behavioural | Adolescents |
Primary outcome
Fat distribution, insulin sensitivity, glucose production, gluconeogenesis, glycogenolysis
Time frame: In response to a 12 wk exercise program.
1 secondary outcome
Lipolysis, blood lipids, adiponectin, leptin and CRP
Time frame: In response to a 12 wk exercise program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
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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.
Agneta L Sunehag, M.D., Ph.D principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise and Obesity, run by National Institutes of Health (NIH) 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Jun 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agneta L Sunehag, M.D., Ph.D. (713 798 6725, asunehag@bcm.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat distribution, insulin sensitivity, glucose production, gluconeogenesis, glycogenolysis (time frame: In response to a 12 wk exercise program.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2011.