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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00777634
Other study ID # 2005-P-000779
Secondary ID
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


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
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