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Completed

NCT Number: NCT00368667

Energy Homeostasis in Anorexia Nervosa

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

New York State Psychiatric Institute, Unit 98

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Important dates

Study start
2000
Study completion
2004
First posted
Aug 25, 2006
Registry last updated
Jan 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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