Does Metabolic Syndrome Exist in Anorexia Nervosa? | NCT00271921

Studies
Does Metabolic Syndrome Exist in Anorexia Nervosa?

NCT00271921

Sponsor

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

Status

Completed

Last Update Posted

Dec 18, 2012Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Anorexia Nervosa
Metabolic Syndrome

Interventions

Calorie controlled diet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R03DK066033	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Dec 29, 2005

First Submission Date that Met QC Criteria

Jan 3, 2006

First Posted Date

Jan 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2012

Last Update Posted Date

Dec 18, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Calorie controlled diet	Behavioral

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Luke's Roosevelt Hosptial Center		New York	New York	10025	United States
New York State Psychiatric Institute/Columbia University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21448937	Derived	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.
20127939	Derived	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.

ID	Term
D000856	Anorexia Nervosa
D024821	Metabolic Syndrome
D001068	Feeding and Eating Disorders

ID	Term
D001523	Mental Disorders
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D002149	Energy Intake