Does Metabolic Syndrome Exist in Anorexia Nervosa? - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 29, 2005

Last Updated Date

January 8, 2008

Start Date ^†

September 2005

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00271921 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Does Metabolic Syndrome Exist in Anorexia Nervosa?

Official Title ^†

Does Metabolic Syndrome Exist in Anorexia Nervosa?

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.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Prospective

Condition ^†

Anorexia Nervosa
Metabolic Syndrome

Intervention ^†

Behavioral: Calorie controlled diet

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Estimated Enrollment ^†

Completion Date

June 2007

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00271921

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

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

Collaborators ^††

Investigators ^†

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

Information Provided By

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

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.