Neural Functioning of Feeding Centers in Obese Youth

Completed

• Conditions: Insulin Resistance; Obesity

• Registration Number: NCT01808846
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2012-10-30
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-11
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States