Skip to main content
OpenTrials
Completed

NCT Number: NCT01808846

Neural Functioning of Feeding Centers in Obese Youth

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. measure of cerebral blood flow response to fructose ingestion

    Time frame: Baseline and 2 year follow up

    fmri on 3T to measure blood flow response after ingestion of fructose drink

Other outcomes

  1. measure of BOLD signal brain reactivity to food cues

    Time frame: Baseline and 2 year follow up

    fmri on 3T to measure blood flow response to visually presented food cues

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Mar 11, 2013
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.