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Neural Functioning of Feeding Centers in Obese Youth

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Yale University

Status

Completed

Conditions

Insulin Resistance
Obesity

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT01808846
1001006251
R01DK085577 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

51 patients

Sex

All

Ages

12 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

51 participants in 3 patient groups

Lean Adolescents
Description:
Kids aged 12-17 with body mass index less than 25% and normal glucose tolerance test results
Obese Insulin Sensitive
Description:
Obese Insulin Sensitive Adolescents aged 12-17 with BMI\>95th% and whole body insulin sensitivity index \> 3.
Obese Insulin Resistant Adolscent
Description:
Obese Insulin Resistant Adolescents 12-17 with BMI\> 95th% and WBISI\<1.2.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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