Does Metabolic Syndrome Exist in Anorexia Nervosa?

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00271921
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Duration (Months): 21
• Patients Per Site: 25
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa; Metabolic Syndrome	Behavioral: Calorie controlled diet

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Does Metabolic Syndrome Exist in Anorexia Nervosa?
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Luke's Roosevelt Hosptial Center	New York	New York	United States	10025
2	New York State Psychiatric Institute/Columbia University	New York	New York	United States	10032

Sponsors and Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Laurel Mayer, MD, New York State Psychiatric Institute/Columbia University
• Principal Investigator: Henry Ginsberg, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00271921
• Other Study ID Numbers: R03 DK66033 (completed)
• First Posted: Jan 4, 2006
• Last Update Posted: Dec 18, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by , ,: eating disorders; anorexia nervosa; body fat distribution; metabolic syndrome; visceral adipose tissue
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome; Anorexia; Anorexia Nervosa

Study Results

No Results Posted as of Dec 18, 2012