Energy Homeostasis in Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Energy Homeostasis in Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368667
• Other study ID #: DK 02749 (completed)
• Status: Completed
• Phase: N/A
• First received: August 24, 2006
• Last updated: January 12, 2010
• Start date: April 2000
• Est. completion date: December 2004

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute, Unit 98	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mayer L, Walsh BT, Pierson RN Jr, Heymsfield SB, Gallagher D, Wang J, Parides MK, Leibel RL, Warren MP, Killory E, Glasofer D. Body fat redistribution after weight gain in women with anorexia nervosa. Am J Clin Nutr. 2005 Jun;81(6):1286-91. — View Citation