Trial Outcomes & Findings for Follow-Up Extension to the Family Study of Binge Eating Disorder (NCT NCT00777634)

NCT ID: NCT00777634

Last Updated: 2012-05-29

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 268 participants
• Primary outcome timeframe: Baseline to 5 years
• Results posted on: 2012-05-29

Participant Flow

Participant milestones

Measure	Binge Eating Disorder (BED) Individuals who meet criteria for binge eating disorder.	Without BED Individuals who do not meet criteria for binge eating disorder.
Overall Study STARTED	134	134
Overall Study COMPLETED	129	133
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Binge Eating Disorder (BED) n=134 Participants Individuals who meet criteria for binge eating disorder.	Without BED n=134 Participants Individuals who do not meet criteria for binge eating disorder.	Total n=268 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	134 Participants n=5 Participants	134 Participants n=7 Participants	268 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	47.0 years STANDARD_DEVIATION 13.2 • n=5 Participants	47.8 years STANDARD_DEVIATION 12.9 • n=7 Participants	47.4 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	102 Participants n=7 Participants	209 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	32 Participants n=7 Participants	59 Participants n=5 Participants
Region of Enrollment United States	134 participants n=5 Participants	134 participants n=7 Participants	268 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Binge Eating Disorder (BED) n=129 Participants Individuals who meet criteria for binge eating disorder.	Without BED n=133 Participants Individuals who do not meet criteria for binge eating disorder.
Incidence of Diagnosis of Dyslipidemia	34 participants	18 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Binge Eating Disorder (BED) n=129 Participants Individuals who meet criteria for binge eating disorder.	Without BED n=133 Participants Individuals who do not meet criteria for binge eating disorder.
Incidence of Diagnosis of Hypertension	25 participants	18 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Binge Eating Disorder (BED) n=129 Participants Individuals who meet criteria for binge eating disorder.	Without BED n=133 Participants Individuals who do not meet criteria for binge eating disorder.
Incidence of Diagnosis of Type 2 Diabetes	13 participants	10 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Binge Eating Disorder (BED) n=129 Participants Individuals who meet criteria for binge eating disorder.	Without BED n=133 Participants Individuals who do not meet criteria for binge eating disorder.
Incidence of Diagnosis of Any Metabolic Syndrome Component	53 participants	37 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Binge Eating Disorder (BED) n=129 Participants Individuals who meet criteria for binge eating disorder.	Without BED n=133 Participants Individuals who do not meet criteria for binge eating disorder.
Incidence of Diagnosis of Two or More Metabolic Syndrome Components	18 participants	8 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Binge Eating Disorder (BED) n=129 Participants Individuals who meet criteria for binge eating disorder.	Without BED n=133 Participants Individuals who do not meet criteria for binge eating disorder.
Incidence of Diagnosis of Three or More Metabolic Syndrome Components	1 participants	1 participants

Adverse Events

Binge Eating Disorder (BED)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Without BED

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Coordinator

McLean Hospital

Phone: 617-855-2984

Email: eryan@mclean.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place