NCT01808846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 11, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

6.6 years

First QC Date

October 30, 2012

Last Update Submit

April 25, 2017

Conditions

ObesityInsulin Resistance

Keywords

ObesityInsulin Resistancefunctional magnetic resonance imagingglucosefructosehypothalamusneuronal circuitsfeeding behavior

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • measure of cerebral blood flow response to fructose ingestion

    Baseline and 2 year follow up

Other Outcomes (1)

  • measure of BOLD signal brain reactivity to food cues

    Baseline and 2 year follow up

Study Arms (3)

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.

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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
  • +8 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

Related Publications (2)

  • Jastreboff AM, Sinha R, Arora J, Giannini C, Kubat J, Malik S, Van Name MA, Santoro N, Savoye M, Duran EJ, Pierpont B, Cline G, Constable RT, Sherwin RS, Caprio S. Altered Brain Response to Drinking Glucose and Fructose in Obese Adolescents. Diabetes. 2016 Jul;65(7):1929-39. doi: 10.2337/db15-1216. Epub 2016 Apr 5.

    PMID: 27207544DERIVED

  • Jastreboff AM, Lacadie C, Seo D, Kubat J, Van Name MA, Giannini C, Savoye M, Constable RT, Sherwin RS, Caprio S, Sinha R. Leptin is associated with exaggerated brain reward and emotion responses to food images in adolescent obesity. Diabetes Care. 2014 Nov;37(11):3061-8. doi: 10.2337/dc14-0525. Epub 2014 Aug 19.

    PMID: 25139883DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

ObesityInsulin ResistanceFeeding Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior, AnimalBehavior

Study Officials

  • Sonia Caprio, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

October 30, 2012

First Posted

March 11, 2013

Study Start

July 1, 2010

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

April 27, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)