Neural Functioning of Feeding Centers in Obese Youth

April 25, 2017 updated by: Sonia Caprio, Yale University

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 2 year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 2 year follow up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 2 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

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

Investigators

  • Principal Investigator: Sonia Caprio, M.D., Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2010

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

October 30, 2012

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimate)

March 11, 2013

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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