Energy Homeostasis in Anorexia Nervosa

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00368667
First received: August 24, 2006
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition
Anorexia Nervosa

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Energy Homeostasis in Anorexia Nervosa

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 120
Study Start Date: April 2000
Estimated Study Completion Date: December 2004
Detailed Description:

Anorexia Nervosa (AN) is a psychiatric illness that is characterized by extreme weight loss and severe body image distortions. In this study, we are examining changes in body composition, metabolic rate, and reproductive function before and after treatment for AN. More specifically, we are testing the hypotheses that 1)Weight-restored patients with AN have elevated resting energy expenditure (REE) compared to controls, 2) Weight-restored patients with AN have a central disposition of body fat compared to controls, 3) Weight-restored patients with AN who gain the most fat centrally will have the least improvement on psychological measures, 4) Weight-restored patients with AN will have leptin levels out of proportion to body fat mass. It will also investigate the relationship between REE and leptin with respect to the return of menses.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Patients:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

Inclusion criteria:

  • 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

Exclusion criteria:

  • On medication*
  • Pregnant or lactating
  • Significant medical problem
  • Non-removable metal on/in their body (e.g. metal pacemaker, surgical clips, metallic-ink tattoos)

    • At the time of testing, subjects will be free of fluoxetine for 6 weeks, and free of all other medications for a minimum of 2 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368667

Locations
United States, New York
New York State Psychiatric Institute, Unit 98
New York, New York, United States, 10032
Sponsors and Collaborators
Investigators
Principal Investigator: Laurel Mayer, MD New York State Psychiatric Institute
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00368667     History of Changes
Other Study ID Numbers: DK 02749 (completed)
Study First Received: August 24, 2006
Last Updated: January 12, 2010
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Anorexia Nervosa
Body Composition
Metabolic Rate

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014