NCT01916538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22,445

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 14, 2016

Status Verified

October 1, 2016

Enrollment Period

3.1 years

First QC Date

July 23, 2013

Last Update Submit

December 13, 2016

Conditions

Anorexia Nervosa

Keywords

anorexia nervosageneticsgeneeating disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Cases

Individuals with a current or past diagnosis of anorexia nervosa

Controls

Individuals who have never been diagnosed with an eating disorder

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with a lifetime diagnosis of anorexia nervosa

You may qualify if:

  • Lifetime history of anorexia nervosa (cases)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • 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.

    PMID: 30287268DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

The blood sample participants provide will be used to identify biological characteristics and other biological "markers." Some analyses will include genetic analyses which are measured using DNA and can look at places in DNA, and others can analyze most of the genome. Other analyses measure a large number of proteins. Still others assess the messenger substance (called RNA) that transfers information from DNA to protein. Investigators plan to store the blood specimens and data indefinitely. Investigators will be collecting DNA to permit immediate and future genetic analyses and analyses of immune, endocrine, and proteins. All blood will be biobanked indefinitely to allow for assays that may become available in the future analyses.

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cynthia Bulik, PhD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

  • Patrick Sullivan, MD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2013

First Posted

August 5, 2013

Study Start

June 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 14, 2016

Record last verified: 2016-10

Locations

US(1)