Clinical trial NCT01808846: Neural Functioning of Feeding Centers in Obese Youth
Official title: Neural Functioning of Feeding Centers in Obese Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Insulin Resistance
Keywords: Obesity
Insulin Resistance
functional magnetic resonance imaging
glucose
fructose
hypothalamus
neuronal circuits
feeding behavior
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-03-11
Enrollment: 51
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

* (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)

Exclusion Criteria

* 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

Primary outcomes:
measure: measure of cerebral blood flow response to glucose ingestion
timeFrame: Baseline and 2 year follow up
Secondary outcomes:
measure: measure of cerebral blood flow response to fructose ingestion
timeFrame: Baseline and 2 year follow up
Other outcomes:
measure: measure of BOLD signal brain reactivity to food cues
timeFrame: Baseline and 2 year follow up
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Sonia Caprio, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Jastreboff 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.