Anorexia NervosaANGINCT01916538
Anorexia Nervosa Genetics Initiative
An observational study of Anorexia Nervosa, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 22,445 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals with a lifetime diagnosis of anorexia nervosa
Who may be able to join
- Lifetime history of anorexia nervosa (cases)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, genetics, gene, eating disorder
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Individuals with a current or past diagnosis of anorexia nervosa | |
| Controls | Individuals who have never been diagnosed with an eating disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 22,445 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Bulik, PhD, Principal investigator, University of North CarolinaPatrick Sullivan, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916538
- Sponsor's protocol ID
- 13-0081
- Acronym
- ANGI
- Status last verified
- Oct 2016
- First submitted
- 23 Jul 2013
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30287268
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anorexia Nervosa Genetics Initiative
- ClinicalTrials.gov ID
- NCT01916538
- Acronym / sponsor ID
- ANGI / 13-0081
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, genetics, gene, eating disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,445 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Individuals with a current or past diagnosis of anorexia nervosa |
| Controls | – | –Individuals who have never been diagnosed with an eating disorder |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with a lifetime diagnosis of anorexia nervosa
Key inclusion criteria (1 listed)
- Lifetime history of anorexia nervosa (cases)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Derived from this study: PubMed 30287268Thornton 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.
- Research study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Bulik, PhD principal investigator
University of North Carolina
Patrick Sullivan, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic differences (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01916538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2016.