Follow-Up Extension to the Family Study of Binge Eating Disorder

Binge Eating Disorder Clinical Trial

Official title:

Follow-Up Extension to the Family Study of Binge Eating Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777634
• Other study ID #: 2005-P-000779
• Status: Completed
• Phase: N/A
• First received: October 20, 2008
• Last updated: April 23, 2012
• Start date: June 2005
• Est. completion date: November 2009

Study information

• Verified date: April 2012
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Disease
• Eating Disorders

Intervention

Other:
• No intervention.
There is no intervention used in this study. Cohort members are interviewed and blood pressure, weight, and laboratory specimens are obtained.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	Ortho-McNeil Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Diagnosis of Dyslipidemia	The number of participants to acquire a new diagnosis of high cholesterol (dyslipidemia) over the course of the baseline to five-year followup.	Baseline to 5 years	No
Primary	Incidence of Diagnosis of Hypertension	The number of participants to acquire a new diagnosis of high blood pressure(hypertension) over the course of the baseline to five-year followup.	Baseline to 5 years	No
Primary	Incidence of Diagnosis of Type 2 Diabetes	The number of participants to acquire a new diagnosis of Type 2 Diabetes over the course of the baseline to five-year followup.	Baseline to 5 years	No
Primary	Incidence of Diagnosis of Any Metabolic Syndrome Component	The number of participants to acquire a new diagnosis of one component of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.	Baseline to 5 years	No
Primary	Incidence of Diagnosis of Two or More Metabolic Syndrome Components	The number of participants to acquire a new diagnosis of two or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.	Baseline to 5 years	No
Primary	Incidence of Diagnosis of Three or More Metabolic Syndrome Components	The number of participants to acquire a new diagnosis of three or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.	Baseline to 5 years	No