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| Name | Class |
|---|---|
| Ortho-McNeil Janssen Scientific Affairs, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Binge eating disorder (BED) | Individuals who meet criteria for binge eating disorder. |
| |
| Without BED | Individuals who do not meet criteria for binge eating disorder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention. | Other | There is no intervention used in this study. Cohort members are interviewed and blood pressure, weight, and laboratory specimens are obtained. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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This study includes individuals with binge eating disorder, individuals without binge eating disorder, and their relatives.
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| Name | Affiliation | Role |
|---|---|---|
| James I Hudson, M.D., Sc.D. | Mclean Hospital | Principal Investigator |
| Harrison G Pope, M.D. | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20427731 | Derived | Hudson JI, Lalonde JK, Coit CE, Tsuang MT, McElroy SL, Crow SJ, Bulik CM, Hudson MS, Yanovski JA, Rosenthal NR, Pope HG Jr. Longitudinal study of the diagnosis of components of the metabolic syndrome in individuals with binge-eating disorder. Am J Clin Nutr. 2010 Jun;91(6):1568-73. doi: 10.3945/ajcn.2010.29203. Epub 2010 Apr 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Binge Eating Disorder (BED) | Individuals who meet criteria for binge eating disorder. |
| FG001 | Without BED | Individuals who do not meet criteria for binge eating disorder. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Binge Eating Disorder (BED) | Individuals who meet criteria for binge eating disorder. |
| BG001 | Without BED | Individuals who do not meet criteria for binge eating disorder. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | Baseline to 5 years |
|
|
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This was an observational study, and so no participants were at risk. No intervention was administered.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Binge Eating Disorder (BED) | Individuals who meet criteria for binge eating disorder. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | McLean Hospital | 617-855-2984 | eryan@mclean.harvard.edu |
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| ID | Term |
|---|---|
| D056912 | Binge-Eating Disorder |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Baseline to 5 years |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 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. | Posted | Number | participants | Baseline to 5 years |
|
|
|
| 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. | Posted | Number | participants | Baseline to 5 years |
|
|
|
| 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. | Posted | Number | participants | Baseline to 5 years |
|
|
|
| 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. | Posted | Number | participants | Baseline to 5 years |
|
|
|
| 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. | Posted | Number | participants | Baseline to 5 years |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Without BED | Individuals who do not meet criteria for binge eating disorder. | 0 | 0 | 0 | 0 |
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