Neural Functioning of Feeding Centers in Obese Youth

Obesity Clinical Trial

Official title:

Neural Functioning of Feeding Centers in Obese Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808846
• Other study ID #: 1001006251
• Secondary ID: R01DK085577
• Status: Completed
• Phase: N/A
• First received: October 30, 2012
• Last updated: April 25, 2017
• Start date: July 2010
• Est. completion date: February 2017

Study information

• Verified date: April 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	measure of BOLD signal brain reactivity to food cues	fmri on 3T to measure blood flow response to visually presented food cues	Baseline and 2 year follow up
Primary	measure of cerebral blood flow response to glucose ingestion	fmri on 3T to measure blood flow response after ingestion of glucose drink	Baseline and 2 year follow up
Secondary	measure of cerebral blood flow response to fructose ingestion	fmri on 3T to measure blood flow response after ingestion of fructose drink	Baseline and 2 year follow up