NCT00271921

Brief Summary

The purpose of this study is to examine whether body fat distribution changes that occur with weight gain in women recovering from anorexia nervosa are transient or persistent, and if they are associated with other features of Metabolic Syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

2 active sites

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

September 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

December 18, 2012

Status Verified

December 1, 2012

Enrollment Period

1.7 years

First QC Date

December 29, 2005

Last Update Submit

December 17, 2012

Conditions

Keywords

eating disordersanorexia nervosabody fat distributionmetabolic syndromevisceral adipose tissue

Interventions

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV diagnosis of Anorexia Nervosa (except amenorrhea) (restricting or binge eating/purging subtype)
  • Female
  • Age 18-40
  • Medically stable
  • Participation in inpatient or daypatient treatment sufficient to restore patient to a BMI of at least 19.5kg/m²

You may not qualify if:

  • Additional Major Axis I disorder (including substance abuse or dependence
  • On daily prescription medication (including oral contraceptives)
  • History of suicide attempt or other self-injurious behavior within the previous 6 months
  • Significant current or past medical illness,including diabetes mellitus, heart disease
  • Indwelling metallic object (e.g., pacemaker,pump), non-removable metal jewelry or recent metallic ink tattoo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Luke's Roosevelt Hosptial Center

New York, New York, 10025, United States

Location

New York State Psychiatric Institute/Columbia University

New York, New York, 10032, United States

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Anorexia NervosaMetabolic SyndromeFeeding and Eating Disorders

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Mental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Laurel Mayer, MD

    New York State Psychiatric Institute/Columbia University

    PRINCIPAL INVESTIGATOR
  • Henry Ginsberg, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

December 29, 2005

First Posted

January 4, 2006

Study Start

September 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

December 18, 2012

Record last verified: 2012-12

Locations