Completed

Neural Functioning of Feeding Centers in Obese Youth

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What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Behavior+12

+ Behavior, Animal

+ Body Weight

From 12 to 17 Years
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: July 2010
See protocol details

Summary

Principal SponsorYale University
Last updated: April 27, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01808846
Principal SponsorYale University
Last updated: April 27, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

51 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBehavior, AnimalBody WeightHyperinsulinismMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweightFeeding BehaviorInsulin ResistanceObesity

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Yale University

New Haven, United StatesOpen Yale University in Google Maps
CompletedOne Study Center