NCT01719484

Brief Summary

To examine the influence of obesity on brain activation during food cue, stress, and neutral relaxing conditions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

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

May 1, 2008

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

5.8 years

First QC Date

October 29, 2012

Last Update Submit

July 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • No outcome measures for this study, this is an imaging study only

    Upon study completion

Study Arms (2)

Healthy

Subjects deemed to be medically healthy

Obese

Subjects deemed to be medically obese

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

30 obese subjects and 30 matched healthy controls will be recruited for this study.

You may qualify if:

  • Between ages 18-50 years old.
  • Able to read and write.
  • negative urine toxicology screens during intake appointments indicating no history of current or past dependence on alcohol or illicit drug use.
  • WOMEN: have a regular menstrual cycle.
  • BMI: 30 \< BMI \< 35 for obese subjects (upper limit of 35 selected given our experience with heavier individuals fitting comfortably in the fMRI scanner) and 18.5 \< BMI \<25 for normal weight subjects (Institute, 2006)

You may not qualify if:

  • any major neurological illness or injury and any current or prior clinically significant mental health (including PTSD) or substance use disorder (with exception of nicotine dependence) as determined by SCID interview;
  • Regular use of any psychoactive drugs including anxiolytics and antidepressants.
  • Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded.
  • Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded including subjects who work as welders.
  • Women on oral contraceptives, peri- and post-menopausal women, and pregnant or lactating women (as alterations in stress response are associated with these states).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marc N Potenza, MD, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2012

First Posted

November 1, 2012

Study Start

May 1, 2008

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 13, 2022

Record last verified: 2022-07

Locations