Neural Functioning of Feeding Centers in Obese Youth

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT01808846

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Location

79.1

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Insulin Resistance

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

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Neural Functioning of Feeding Centers in Obese Youth

Actual Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

measure of cerebral blood flow response to glucose ingestion [Baseline and 2 year follow up]
fmri on 3T to measure blood flow response after ingestion of glucose drink

Secondary Outcome Measures

measure of cerebral blood flow response to fructose ingestion [Baseline and 2 year follow up]
fmri on 3T to measure blood flow response after ingestion of fructose drink

Other Outcome Measures

measure of BOLD signal brain reactivity to food cues [Baseline and 2 year follow up]
fmri on 3T to measure blood flow response to visually presented food cues

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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