NCT00368667

Brief Summary

The purpose of this study is to investigate the potential biological predispositions that contribute to the difficulty patients with anorexia nervosa have in maintaining normal weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2000

Longer than P75 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

April 1, 2000

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2006

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

First QC Date

August 24, 2006

Last Update Submit

January 12, 2010

Conditions

Keywords

Anorexia NervosaBody CompositionMetabolic Rate

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV diagnosis of Anorexia Nervosa
  • BMI ≤ 17.5kg/m2 (equivalent to 80% of ideal body weight)
  • Medically stable
  • Participation in in-patient treatment sufficient to restore patient to a BMI of at least 19kg/m2

You may not qualify if:

  • On medication\*
  • Current substance abuse or dependence
  • History of suicide attempt or other self-injurious behavior within the previous 6 months
  • Non-removable metal on/in their body (e.g. metal pacemaker, surgical clips, metallic-ink tattoos)
  • Controls:
  • No current psychiatric disorder (including eating disorder, depression, bipolar disorder, schizophrenia, substance abuse/dependence)
  • No history of an eating disorder
  • BMI greater than 19kg/m2 and less than 21kg/m2
  • Weight stable (+/- 2kg) for the previous 6 months
  • No history of excessive or repeated dieting
  • No history of excessive exercise (defined as greater than 6 hours/week)
  • Regular menstrual cycles
  • On medication\*
  • Pregnant or lactating
  • Significant medical problem
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute, Unit 98

New York, New York, 10032, United States

Location

Related Publications (4)

  • Mayer L, Walsh BT, Pierson RN Jr, Heymsfield SB, Gallagher D, Wang J, Parides MK, Leibel RL, Warren MP, Killory E, Glasofer D. Body fat redistribution after weight gain in women with anorexia nervosa. Am J Clin Nutr. 2005 Jun;81(6):1286-91. doi: 10.1093/ajcn/81.6.1286.

  • Schebendach J, Mayer LE, Devlin MJ, Attia E, Walsh BT. Dietary energy density and diet variety as risk factors for relapse in anorexia nervosa: a replication. Int J Eat Disord. 2012 Jan;45(1):79-84. doi: 10.1002/eat.20922. Epub 2011 Mar 29.

  • Bodell LP, Mayer LE. Percent body fat is a risk factor for relapse in anorexia nervosa: a replication study. Int J Eat Disord. 2011 Mar;44(2):118-23. doi: 10.1002/eat.20801.

  • Mayer LE, Klein DA, Black E, Attia E, Shen W, Mao X, Shungu DC, Punyanita M, Gallagher D, Wang J, Heymsfield SB, Hirsch J, Ginsberg HN, Walsh BT. Adipose tissue distribution after weight restoration and weight maintenance in women with anorexia nervosa. Am J Clin Nutr. 2009 Nov;90(5):1132-7. doi: 10.3945/ajcn.2009.27820. Epub 2009 Sep 30.

Related Links

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Laurel Mayer, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 24, 2006

First Posted

August 25, 2006

Study Start

April 1, 2000

Study Completion

December 1, 2004

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations