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Completed

NCT Number: NCT00777634

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention.

Other

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

Primary outcomes

  1. Incidence of Diagnosis of Dyslipidemia

    Time frame: Baseline to 5 years

    The number of participants to acquire a new diagnosis of high cholesterol (dyslipidemia) over the course of the baseline to five-year followup.

  2. Incidence of Diagnosis of Hypertension

    Time frame: Baseline to 5 years

    The number of participants to acquire a new diagnosis of high blood pressure(hypertension) over the course of the baseline to five-year followup.

  3. Incidence of Diagnosis of Type 2 Diabetes

    Time frame: Baseline to 5 years

    The number of participants to acquire a new diagnosis of Type 2 Diabetes over the course of the baseline to five-year followup.

  4. Incidence of Diagnosis of Any Metabolic Syndrome Component

    Time frame: Baseline to 5 years

    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.

  5. Incidence of Diagnosis of Two or More Metabolic Syndrome Components

    Time frame: Baseline to 5 years

    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.

  6. Incidence of Diagnosis of Three or More Metabolic Syndrome Components

    Time frame: Baseline to 5 years

    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.

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • Ortho-McNeil Janssen Scientific Affairs, LLC

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Oct 22, 2008
Registry last updated
May 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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