Anorexia Nervosa Genetics Initiative | NCT01916538

Studies
Anorexia Nervosa Genetics Initiative

NCT01916538

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Dec 14, 2016Estimated

Enrollment

22,445Actual

Phase

Not provided

Conditions

Anorexia Nervosa

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Jul 23, 2013

First Submission Date that Met QC Criteria

Aug 1, 2013

First Posted Date

Aug 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2016

Last Update Posted Date

Dec 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Anorexia Nervosa Genetics Initiative (ANGI) is the largest and most rigorous genetic investigation of eating disorders ever conducted. Researchers in the United States, Sweden, Australia, and Denmark will collect clinical information and blood samples from over 13,000 individuals with anorexia nervosa and individuals without an eating disorder.

ANGI represents a global effort to detect genetic variation that contributes to this potentially life-threatening illness. The goal of the research study is to transform knowledge about the causes of eating disorders to work toward greater understanding and ultimately a cure.

If you have suffered from anorexia nervosa at any point in your life, you can help us achieve this goal. Your contribution would include a brief questionnaire and a blood sample. If you have never had anorexia nervosa, but still want to contribute, we invite your participation as well.

Detailed Description

Participation in this genetics study requires participants to answer some questions online, about eating behaviors (about 15-30 minutes) and to provide a single blood sample that should take only a few minutes.

To obtain the blood sample, investigators will mail you a kit which participants would take to their primary care provider or your local laboratory to have them draw a small sample of blood (about 40 mL, which is less than three tablespoons). The study is also working with a mobile phlebotomy company that can come to your home or location of your choice to draw your blood and ship it at no cost to you. Once the sample is drawn, participants or the mobile phlebotomist will place it in a box and contact FedEx for pick up. There is no cost for the FedEx shipment. Participants will also fill out the reimbursement form and send it and the receipt to our office. Investigators will reimburse participants for the cost of the blood draw. The samples will be studied directly or reprogrammed prior to further study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

22,445Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cases		Individuals with a current or past diagnosis of anorexia nervosa
Controls		Individuals who have never been diagnosed with an eating disorder

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genetic differences	Genetic variation between two groups of people: 1) people with a history of anorexia nervosa and 2) people who have never had an eating disorder will be assessed	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lifetime history of anorexia nervosa (cases)

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Individuals with a lifetime diagnosis of anorexia nervosa

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cynthia Bulik, PhD	University of North Carolina	Principal Investigator
Patrick Sullivan, MD	University of North Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina		Chapel Hill	North Carolina	27599	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30287268	Derived	Thornton LM, Munn-Chernoff MA, Baker JH, Jureus A, Parker R, Henders AK, Larsen JT, Petersen L, Watson HJ, Yilmaz Z, Kirk KM, Gordon S, Leppa VM, Martin FC, Whiteman DC, Olsen CM, Werge TM, Pedersen NL, Kaye W, Bergen AW, Halmi KA, Strober M, Kaplan AS, Woodside DB, Mitchell J, Johnson CL, Brandt H, Crawford S, Horwood LJ, Boden JM, Pearson JF, Duncan LE, Grove J, Mattheisen M, Jordan J, Kennedy MA, Birgegard A, Lichtenstein P, Norring C, Wade TD, Montgomery GW, Martin NG, Landen M, Mortensen PB, Sullivan PF, Bulik CM. The Anorexia Nervosa Genetics Initiative (ANGI): Overview and methods. Contemp Clin Trials. 2018 Nov;74:61-69. doi: 10.1016/j.cct.2018.09.015. Epub 2018 Oct 1.

ID	Term
D000856	Anorexia Nervosa
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