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Neural Functioning of Feeding Centers in Obese Youth

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ClinicalTrials.gov Identifier: NCT01808846
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Sonia Caprio, 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.


Condition or disease
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.

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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 : July 2010
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Clinic patients of Dr. Caprio at the Yale Pediatric Obesity Clinic who have undergone oral glucose tolerance testing (OGTT) and found to be insulin resistant or sensitive and/or previous research subjects who were found to be insulin resistant or sensitive and who agreed to be contacted for other studies will be contacted.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808846


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Sonia Caprio, M.D. Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sonia Caprio, Professor of Pediatrics, Yale University
ClinicalTrials.gov Identifier: NCT01808846     History of Changes
Other Study ID Numbers: 1001006251
R01DK085577 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sonia Caprio, Yale University:
Obesity
Insulin Resistance
functional magnetic resonance imaging
glucose
fructose
hypothalamus
neuronal circuits
feeding behavior

Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs