Clinical trial NCT00368667: Energy Homeostasis in Anorexia Nervosa
Official title: Energy Homeostasis in Anorexia Nervosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa
Body Composition
Metabolic Rate
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2006-08-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute, Unit 98
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Laurel Mayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/ajcn/81.6.1286.
citation: 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.
citation: 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.
citation: Mayer LE, Klein DA, Black E, Attia E, Shen W, Mao X, Shungu DC, Punyanita M, Gallagher D, Wang J, Heymsfield SB, Hirsch J, Ginsberg HN, Walsh BT. Adipose tissue distribution after weight restoration and weight maintenance in women with anorexia nervosa. Am J Clin Nutr. 2009 Nov;90(5):1132-7. doi: 10.3945/ajcn.2009.27820. Epub 2009 Sep 30.