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

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ClinicalTrials.gov Identifier: NCT00777634
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : May 29, 2012
Last Update Posted : May 29, 2012
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
James I. Hudson, MD, Mclean Hospital

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition Binge Eating Disorder
Intervention Other: No intervention.
Enrollment 268
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Binge Eating Disorder (BED) Without BED
Hide Arm/Group Description Individuals who meet criteria for binge eating disorder. Individuals who do not meet criteria for binge eating disorder.
Period Title: Overall Study
Started 134 134
Completed 129 133
Not Completed 5 1
Arm/Group Title Binge Eating Disorder (BED) Without BED Total
Hide Arm/Group Description Individuals who meet criteria for binge eating disorder. Individuals who do not meet criteria for binge eating disorder. Total of all reporting groups
Overall Number of Baseline Participants 134 134 268
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 134 participants 268 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
134
 100.0%
134
 100.0%
268
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 134 participants 134 participants 268 participants
47.0  (13.2) 47.8  (12.9) 47.4  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 134 participants 268 participants
Female
107
  79.9%
102
  76.1%
209
  78.0%
Male
27
  20.1%
32
  23.9%
59
  22.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 134 participants 134 participants 268 participants
134 134 268
1.Primary Outcome
Title Incidence of Diagnosis of Dyslipidemia
Hide Description The number of participants to acquire a new diagnosis of high cholesterol (dyslipidemia) over the course of the baseline to five-year followup.
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Binge Eating Disorder (BED) Without BED
Hide Arm/Group Description:
Individuals who meet criteria for binge eating disorder.
Individuals who do not meet criteria for binge eating disorder.
Overall Number of Participants Analyzed 129 133
Measure Type: Number
Unit of Measure: participants
34 18
2.Primary Outcome
Title Incidence of Diagnosis of Hypertension
Hide Description The number of participants to acquire a new diagnosis of high blood pressure(hypertension) over the course of the baseline to five-year followup.
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Binge Eating Disorder (BED) Without BED
Hide Arm/Group Description:
Individuals who meet criteria for binge eating disorder.
Individuals who do not meet criteria for binge eating disorder.
Overall Number of Participants Analyzed 129 133
Measure Type: Number
Unit of Measure: participants
25 18
3.Primary Outcome
Title Incidence of Diagnosis of Type 2 Diabetes
Hide Description The number of participants to acquire a new diagnosis of Type 2 Diabetes over the course of the baseline to five-year followup.
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Binge Eating Disorder (BED) Without BED
Hide Arm/Group Description:
Individuals who meet criteria for binge eating disorder.
Individuals who do not meet criteria for binge eating disorder.
Overall Number of Participants Analyzed 129 133
Measure Type: Number
Unit of Measure: participants
13 10
4.Primary Outcome
Title Incidence of Diagnosis of Any Metabolic Syndrome Component
Hide Description 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.
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Binge Eating Disorder (BED) Without BED
Hide Arm/Group Description:
Individuals who meet criteria for binge eating disorder.
Individuals who do not meet criteria for binge eating disorder.
Overall Number of Participants Analyzed 129 133
Measure Type: Number
Unit of Measure: participants
53 37
5.Primary Outcome
Title Incidence of Diagnosis of Two or More Metabolic Syndrome Components
Hide Description 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.
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Binge Eating Disorder (BED) Without BED
Hide Arm/Group Description:
Individuals who meet criteria for binge eating disorder.
Individuals who do not meet criteria for binge eating disorder.
Overall Number of Participants Analyzed 129 133
Measure Type: Number
Unit of Measure: participants
18 8
6.Primary Outcome
Title Incidence of Diagnosis of Three or More Metabolic Syndrome Components
Hide Description 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.
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Binge Eating Disorder (BED) Without BED
Hide Arm/Group Description:
Individuals who meet criteria for binge eating disorder.
Individuals who do not meet criteria for binge eating disorder.
Overall Number of Participants Analyzed 129 133
Measure Type: Number
Unit of Measure: participants
1 1
Time Frame [Not Specified]
Adverse Event Reporting Description This was an observational study, and so no participants were at risk. No intervention was administered.
 
Arm/Group Title Binge Eating Disorder (BED) Without BED
Hide Arm/Group Description Individuals who meet criteria for binge eating disorder. Individuals who do not meet criteria for binge eating disorder.
All-Cause Mortality
Binge Eating Disorder (BED) Without BED
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Binge Eating Disorder (BED) Without BED
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Binge Eating Disorder (BED) Without BED
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study Coordinator
Organization: McLean Hospital
Phone: 617-855-2984
Responsible Party: James I. Hudson, MD, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00777634     History of Changes
Other Study ID Numbers: 2005-P-000779
First Submitted: October 20, 2008
First Posted: October 22, 2008
Results First Submitted: March 9, 2012
Results First Posted: May 29, 2012
Last Update Posted: May 29, 2012