Anorexia Nervosa Genetics Initiative (ANGI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01916538
First received: July 23, 2013
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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 8,000 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 interview and a blood sample. If you have never had anorexia nervosa, but still want to contribute, we invite your participation as well.


Condition
Anorexia Nervosa

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Anorexia Nervosa Genetics Initiative

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Genetic differences [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 8000
Study Start Date: June 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cases
Individuals with a current or past diagnosis of anorexia nervosa
Controls
Individuals who have never been diagnosed with an eating disorder

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 reimbursement form for the cost of the blood draw and 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). Once the sample is drawn, participants 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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Individuals with a lifetime diagnosis of anorexia nervosa

Criteria

Inclusion Criteria:

  • Lifetime history of anorexia nervosa (cases)

Exclusion Criteria:

  • None
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916538

Contacts
Contact: Chris Hilliard, BS 919-966-3065 chris_hilliard@med.unc.edu
Contact: Jessica Baker, PhD 919-966-3065 angi@unc.edu

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

Additional Information:
No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01916538     History of Changes
Other Study ID Numbers: 13-0081
Study First Received: July 23, 2013
Last Updated: January 10, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 28, 2014