Energy Homeostasis in Anorexia Nervosa

NCT ID: NCT00368667

Last Updated: 2010-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-04-30

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Anorexia Nervosa

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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


* 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\*
* 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:


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role lead

Principal Investigators

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Laurel Mayer, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

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New York State Psychiatric Institute, Unit 98

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 15941877 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21448937 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20127939 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19793856 (View on PubMed)

Related Links

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Other Identifiers

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DK 02749 (completed)

Identifier Type: -

Identifier Source: org_study_id

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