Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT00368667
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2006-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Energy Homeostasis in Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2004-12'}, 'lastUpdateSubmitDate': '2010-01-12', 'studyFirstSubmitDate': '2006-08-24', 'studyFirstSubmitQcDate': '2006-08-24', 'lastUpdatePostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Anorexia Nervosa', 'Body Composition', 'Metabolic Rate'], 'conditions': ['Anorexia Nervosa']}, 'referencesModule': {'references': [{'pmid': '15941877', 'type': 'RESULT', '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.'}, {'pmid': '21448937', 'type': 'DERIVED', '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.'}, {'pmid': '20127939', 'type': 'DERIVED', '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.'}, {'pmid': '19793856', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.eatingdisordersclinic.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients:\n\nInclusion Criteria:\n\n* DSM-IV diagnosis of Anorexia Nervosa\n* BMI ≤ 17.5kg/m2 (equivalent to 80% of ideal body weight)\n* Medically stable\n* Participation in in-patient treatment sufficient to restore patient to a BMI of at least 19kg/m2\n\nExclusion Criteria:\n\n* On medication\\*\n* Current substance abuse or dependence\n* History of suicide attempt or other self-injurious behavior within the previous 6 months\n* Non-removable metal on/in their body (e.g. metal pacemaker, surgical clips, metallic-ink tattoos)\n\nControls:\n\nInclusion criteria:\n\n* No current psychiatric disorder (including eating disorder, depression, bipolar disorder, schizophrenia, substance abuse/dependence)\n* No history of an eating disorder\n* BMI greater than 19kg/m2 and less than 21kg/m2\n* Weight stable (+/- 2kg) for the previous 6 months\n* No history of excessive or repeated dieting\n* No history of excessive exercise (defined as greater than 6 hours/week)\n* Regular menstrual cycles\n\nExclusion criteria:\n\n* On medication\\*\n* Pregnant or lactating\n* Significant medical problem\n* Non-removable metal on/in their body (e.g. metal pacemaker, surgical clips, metallic-ink tattoos)\n\n * 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'}, 'identificationModule': {'nctId': 'NCT00368667', 'briefTitle': 'Energy Homeostasis in Anorexia Nervosa', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Energy Homeostasis in Anorexia Nervosa', 'orgStudyIdInfo': {'id': 'DK 02749 (completed)'}}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute, Unit 98', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Laurel Mayer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York State Psychiatric Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}}}}