Clinical trial NCT00777634: Follow-Up Extension to the Family Study of Binge Eating Disorder
Official title: Follow-Up Extension to the Family Study of Binge Eating Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Binge Eating Disorder
Keywords: Binge Eating Disorder
Eating Disorder
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Janssen Scientific Affairs, LLC
First posted: 2008-10-22
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes individuals with binge eating disorder, individuals without binge eating disorder, and their relatives.

Brief summary: This study involves a 2.5 and 5 year follow-up interview for individuals who participated in the initial family study of binge eating disorder. The study includes individuals with and without eating disorder as well as their first degree relatives. As part of the study, participants will be interviewed about their current psychiatric and medical symptoms, their blood pressure will be measured, and laboratory specimens will be obtained.

Detailed description: Previously we completed a family interview study of 150 individuals with binge eating disorder, 150 matched controls, and approximately 888 of their first degree relatives. In follow-up to this, we are interviewing these individuals again at 2.5 and 5 years after their initial interview. During the course of the interview, individuals are asked about their psychiatric and medical history and blood pressure and laboratory specimens are obtained to measure, among other things, fasting lipids and glucose.

Eligibility criteria: Inclusion Criteria:

* Individuals with or without binge eating disorder and their family members who participated in the initial family study of binge eating disorder and agree to be followed up at 2.5 and 5 years.

Exclusion Criteria:

* Unwilling or unable to participate in the follow-up study.

Primary outcomes:
measure: Incidence of Diagnosis of Dyslipidemia
timeFrame: Baseline to 5 years
measure: Incidence of Diagnosis of Hypertension
timeFrame: Baseline to 5 years
measure: Incidence of Diagnosis of Type 2 Diabetes
timeFrame: Baseline to 5 years
measure: Incidence of Diagnosis of Any Metabolic Syndrome Component
timeFrame: Baseline to 5 years
measure: Incidence of Diagnosis of Two or More Metabolic Syndrome Components
timeFrame: Baseline to 5 years
measure: Incidence of Diagnosis of Three or More Metabolic Syndrome Components
timeFrame: Baseline to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: James I Hudson, M.D., Sc.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mclean Hospital
name: Harrison G Pope, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hudson JI, Lalonde JK, Coit CE, Tsuang MT, McElroy SL, Crow SJ, Bulik CM, Hudson MS, Yanovski JA, Rosenthal NR, Pope HG Jr. Longitudinal study of the diagnosis of components of the metabolic syndrome in individuals with binge-eating disorder. Am J Clin Nutr. 2010 Jun;91(6):1568-73. doi: 10.3945/ajcn.2010.29203. Epub 2010 Apr 28.