ObesityNCT01808846
Neural Functioning of Feeding Centers in Obese Youth
An observational study of Obesity and Insulin Resistance, run by Yale University at 1 site in United States.
Trial summary
To explore whether obese adolescents with insulin resistance and relative low leptin levels exhibit functional alterations of the neuronal circuits involved in the regulation of energy metabolism and food seeking behaviors. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Feb 2017
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Clinic patients of Dr. Caprio at the Yale Pediatric Obesity Clinic who have undergone oral glucose tolerance testing (OGTT) and found to be insulin resistant or sensitive and/or previous research subjects who were found to be insulin resistant or sensitive and who agreed to be contacted for other studies will be contacted.
Who may be able to join
- Obese adolescents
- Good general health,
- taking no medication on a chronic basis
- Age 12 to 17 yrs,
- in puberty (girls and boys: Tanner stage II - IV)
- Obese Insulin Resistant Adolescents
Show all 23Show fewer
- (BMI> 95th)
- (WBISI<1.2 plus a low adiponectin <6 ug/dl and
- high triglyceride levels >130mg/dl)
- Obese Insulin Sensitive Adolescents
- (BMI>95th)
- (WBISI >3) plus high adiponectin >8 ug/ml and
- triglyceride levels > 80 mg/dl Girls who begin menstruating must have a negative pregnancy test during the study
- Eligibility criteria for healthy non-obese children and adolescents:
- Brother or sister with obesity
- Age 12 to 17 years
- Normal fasting glucose and lipids in the child, and
- normal OGTT
- No use of any medication known to affect glucose, lipid metabolism and inflammation
- No endocrinopathies
- No use of any antipsychotic medication
- BMI >25th to <75th ( Center for Disease Control (CDC) BMI Charts)
- Minimum weight of 90lbs (CDC Growth Charts)
Who cannot join
- Baseline creatinine >1.0 mg
- Pregnancy
- Presence of endocrinopathies (e.g. Cushing syndrome)
- Cardiac or pulmonary or other significant chronic illness
- Adolescents with psychiatric disorder or with substance abuse determined via self-report.
- Use of anorexic agents No metal implants
Trial locations and contacts
1 site in 1 country.
About this study
To explore whether obese adolescents with insulin resistance and relative low leptin levels exhibit functional alterations of the neuronal circuits involved in the regulation of energy metabolism and food seeking behaviors.
We here propose to test the hypothesis that the reward circuitry is dysregulated in obese adolescents and is related to the degree of insulin resistance and hyperinsulinemia.
Read the detailed description
Functional Magnetic Resonance Imaging (fMRI) provides a non-invasive method to assess the functional pathways affected by nutrient ingestion and therefore can help answer important questions regarding potential differences in the response of brain regions involved in feeding.
- Conditions
- Obesity, Insulin Resistance
- Keywords
- Obesity, Insulin Resistance, functional magnetic resonance imaging, glucose, fructose, hypothalamus, neuronal circuits, feeding behavior
- Medical subject headings
- Obesity, Insulin Resistance, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lean Adolescents | Kids aged 12-17 with body mass index less than 25% and normal glucose tolerance test results | |
| Obese Insulin Sensitive | Obese Insulin Sensitive Adolescents aged 12-17 with BMI>95th% and whole body insulin sensitivity index > 3. | |
| Obese Insulin Resistant Adolscent | Obese Insulin Resistant Adolescents 12-17 with BMI> 95th% and WBISI<1.2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of cerebral blood flow response to glucose ingestion
fmri on 3T to measure blood flow response after ingestion of glucose drink
Measured: Baseline and 2 year follow up
Secondary outcomes (1)
measure of cerebral blood flow response to fructose ingestion
fmri on 3T to measure blood flow response after ingestion of fructose drink
Measured: Baseline and 2 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startJul 2010
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Caprio, Yale University
- Investigators
- Sonia Caprio, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808846
- Sponsor's protocol ID
- 1001006251
- Other IDs
- R01DK085577
- Status last verified
- Apr 2017
- First submitted
- 30 Oct 2012
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jastreboff AM, Sinha R, Arora J, Giannini C, Kubat J, Malik S, Van Name MA, Santoro N, Savoye M, Duran EJ, Pierpont B, Cline G, Constable RT, Sherwin RS, Caprio S. Altered Brain Response to Drinking Glucose and Fructose in Obese Adolescents. Diabetes. 2016 Jul;65(7):1929-39. doi: 10.2337/db15-1216. Epub 2016 Apr 5.
PubMed 27207544Jastreboff AM, Lacadie C, Seo D, Kubat J, Van Name MA, Giannini C, Savoye M, Constable RT, Sherwin RS, Caprio S, Sinha R. Leptin is associated with exaggerated brain reward and emotion responses to food images in adolescent obesity. Diabetes Care. 2014 Nov;37(11):3061-8. doi: 10.2337/dc14-0525. Epub 2014 Aug 19.
PubMed 25139883
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Functioning of Feeding Centers in Obese Youth
- ClinicalTrials.gov ID
- NCT01808846
- Acronym / sponsor ID
- 1001006251
- Conditions
- Obesity, Insulin Resistance
- Keywords
- Obesity, Insulin Resistance, functional magnetic resonance imaging, glucose, fructose, hypothalamus, neuronal circuits, feeding behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2010 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 11 Mar 2013 (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.
To explore whether obese adolescents with insulin resistance and relative low leptin levels exhibit functional alterations of the neuronal circuits involved in the regulation of energy metabolism and food seeking behaviors.
We here propose to test the hypothesis that the reward circuitry is dysregulated in obese adolescents and is related to the degree of insulin resistance and hyperinsulinemia.
Detailed description
Functional Magnetic Resonance Imaging (fMRI) provides a non-invasive method to assess the functional pathways affected by nutrient ingestion and therefore can help answer important questions regarding potential differences in the response of brain regions involved in feeding.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lean Adolescents | – | –Kids aged 12-17 with body mass index less than 25% and normal glucose tolerance test results |
| Obese Insulin Sensitive | – | –Obese Insulin Sensitive Adolescents aged 12-17 with BMI>95th% and whole body insulin sensitivity index > 3. |
| Obese Insulin Resistant Adolscent | – | –Obese Insulin Resistant Adolescents 12-17 with BMI> 95th% and WBISI<1.2. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Clinic patients of Dr. Caprio at the Yale Pediatric Obesity Clinic who have undergone oral glucose tolerance testing (OGTT) and found to be insulin resistant or sensitive and/or previous research subjects who were found to be insulin resistant or sensitive and who agreed to be contacted for other studies will be contacted.
Key inclusion criteria (23 listed)
- Obese adolescents
- Good general health,
- taking no medication on a chronic basis
- Age 12 to 17 yrs,
- in puberty (girls and boys: Tanner stage II - IV)
Key exclusion criteria (6 listed)
- Baseline creatinine >1.0 mg
- Pregnancy
- Presence of endocrinopathies (e.g. Cushing syndrome)
- Cardiac or pulmonary or other significant chronic illness
- Adolescents with psychiatric disorder or with substance abuse determined via self-report.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
measure of cerebral blood flow response to glucose ingestion
Time frame: Baseline and 2 year follow up
fmri on 3T to measure blood flow response after ingestion of glucose drink
1 secondary outcome
measure of cerebral blood flow response to fructose ingestion
Time frame: Baseline and 2 year follow up
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 27 Apr 2017.
- Derived from this study: PubMed 27207544Jastreboff AM, Sinha R, Arora J, Giannini C, Kubat J, Malik S, Van Name MA, Santoro N, Savoye M, Duran EJ, Pierpont B, Cline G, Constable RT, Sherwin RS, Caprio S. Altered Brain Response to Drinking Glucose and Fructose in Obese Adolescents. Diabetes. 2016 Jul;65(7):1929-39. doi: 10.2337/db15-1216. Epub 2016 Apr 5.
- Derived from this study: PubMed 25139883Jastreboff AM, Lacadie C, Seo D, Kubat J, Van Name MA, Giannini C, Savoye M, Constable RT, Sherwin RS, Caprio S, Sinha R. Leptin is associated with exaggerated brain reward and emotion responses to food images in adolescent obesity. Diabetes Care. 2014 Nov;37(11):3061-8. doi: 10.2337/dc14-0525. Epub 2014 Aug 19.
- Individual participant dataSharing planned: No
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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.
Sonia Caprio, M.D. principal investigator
Yale University
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 Obesity and Insulin Resistance, run by Yale University 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 23 inclusion and 6 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 27 Apr 2017. 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?
measure of cerebral blood flow response to glucose ingestion (time frame: Baseline and 2 year follow up). 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 NCT01808846, which also lists 2 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 27 Apr 2017.