Anorexia Nervosa Genetics Initiative (ANGI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01916538
Recruitment Status : Completed
First Posted : August 5, 2013
Last Update Posted : December 14, 2016
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease
Anorexia Nervosa

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.

Study Type : Observational
Actual Enrollment : 22445 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Anorexia Nervosa Genetics Initiative
Study Start Date : June 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Individuals with a current or past diagnosis of anorexia nervosa
Individuals who have never been diagnosed with an eating disorder

Primary Outcome Measures :
  1. Genetic differences [ Time Frame: Baseline ]
    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

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals with a lifetime diagnosis of anorexia nervosa

Inclusion Criteria:

  • Lifetime history of anorexia nervosa (cases)

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01916538

United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Principal Investigator: Cynthia Bulik, PhD University of North Carolina
Principal Investigator: Patrick Sullivan, MD University of North Carolina

Additional Information:
Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01916538     History of Changes
Other Study ID Numbers: 13-0081
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: October 2016

Keywords provided by University of North Carolina, Chapel Hill:
anorexia nervosa
eating disorder

Additional relevant MeSH terms:
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders