[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07726524":3,"trial-entities:NCT07726524":131,"trial-summary:NCT07726524":135},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":28,"study_type":44,"primary_purpose":45,"phases":46,"enrollment_info":47,"interventions":50,"primary_outcomes":51,"secondary_outcomes":56,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":14,"eligibility_criteria":68,"std_ages":80,"locations":83,"central_contacts":124,"overall_officials":127,"references":129,"see_also_links":130},"NCT07726524","1R01HD119553-01A1","3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study","NOT_YET_RECRUITING","2031-05","2026-07","2026-07-24","2027-01","University of California, San Francisco","OTHER",false,"People with anorexia nervosa often become medically unstable because of severe malnutrition and require hospitalization for nutritional rehabilitation. Clinicians currently rely heavily on body weight to assess malnutrition, but body weight does not always reflect the severity of illness. This study will use infrared scanning to assess body composition in adolescents and young adults hospitalized with anorexia nervosa. Researchers will then examine how organ and tissue stores relate to the degree of malnutrition, predict nutritional needs and medical restoration in hospital, and recovery outcomes over the following year. The goal is to develop more individualized approaches to nutritional rehabilitation and improve recovery for individuals with malnutrition due to eating disorders.","Background: The proposed project is aligned with NIH's Strategic Plan for Nutrition Research (SPNR) Objectives 4-2 and 4-3, to reduce the burden of malnutrition in clinical settings. Up to 40% of patients with anorexia nervosa (AN) become medically unstable due to malnutrition and require hospitalization for refeeding; 25% progress to severe and enduring illness. Long, intensive hospitalizations with frequent readmissions drive high healthcare costs in AN. Historically, clinicians have relied on body weight to assess malnutrition and response to intervention. However, body weight lost diagnostic power due to rising BMIs. About one third of patients today are diagnosed with atypical AN (AAN), with medical instability at \"normal\" weight. The upward shift in BMI is reflected globally, leading new recommendations to include body composition to diagnose malnutrition. Emphasis is on low fat free mass (FFM) as a predictor of poor hospital outcomes. However, this has not been examined in hospitalized patients with AN, who are often too medically unstable to transport for research scans. This gap can now be filled with whole-body, infrared, 3-dimensional optical imaging (3DO) at the bedside. Prior work by the investigators showed excellent concordance between 3DO and dual X-ray absorptiometry (DXA) for detecting malnutrition at low BMI and captured changes in FFM with bedside 3DO during refeeding. Proposed project: The investigators will employ a functional approach to body composition, integrating compartment mass with physiologic function, to assess malnutrition and predict short-term and long-term refeeding outcomes across the malnutrition continuum. Prior research on FFM has focused on the skeletal muscle and bone components and long-term risks in AN. In contrast, organ residual mass (ORM), which comprises 43% of FFM, has received little attention despite its central role in refeeding. Profound ORM depletion in AN (loss of 43% cardiac, 22% renal, and 39% hepatic mass) contributes to organ dysfunction, hypometabolism, and refeeding complications. The investigators will generate ORM reference values from large, representative datasets, calculate ORM index z-scores (ORMIz), and examine their correlation with malnutrition at baseline, in response to short-term refeeding intensity, and as a predictor of long-term outcomes in patients across the continuum of malnutrition due to AN. Purpose, hypotheses and design: This multicenter, prospective, observational study will include N=90 hospitalized 15 to 26 year olds with medical instability and malnutrition due to AAN, AN, or extreme AN.\n\nAim 1) Assess clinical utility of ORMIz at admission. Lower baseline ORMIz will: H1) correlate with malnutrition markers, H2) correlate with pre-admission energy imbalance, and H3-Primary) predict refeeding intensity.\n\nAim 2) Monitor response to refeeding in hospital. Change in ORM will correlate with: H1) medical stability, H2) metabolic stability, and H3) lower baseline FM.\n\nAim 3) Predict long-term outcomes. Lower discharge ORMIz will predict poor outcomes at 3, 6, 9, and 12 months. Findings will be rapidly translated into individualized refeeding approaches.",[18,19,20,21,22,23,24,25,26,27],"Anorexia in Adolescence","Anorexia Nervosa","Anorexia Nervosa, Atypical","Anorexia Nervosa, Binge Eating\u002FPurging Type","Anorexia Nervosa Restricting Type","Anorexia Nervosa With Significantly Low Body Weight","Body Composition Changes","Growth & Development","Malnutrition Severe","Malnutrition, Calorie",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Organ residual mass","Body composition","Three-dimensional optical imaging","Optical body scanning","Refeeding","Refeeding syndrome","Nutritional rehabilitation","Resting energy expenditure","Eating disorders","Bioelectrical impedance analysis","Fat-free mass","Adolescent","Young adult","Anorexia nervosa","Growth charts","OBSERVATIONAL",null,[],{"count":48,"type":49},90,"ESTIMATED",[],[52],{"measure":53,"description":54,"timeFrame":55},"Refeeding intensity: caloric load to achieve medical stability (predicted by baseline ORMIz)","Total caloric load required to restore medical stability during hospitalization, analyzed as a function of baseline organ residual mass index z-score (ORMIz). Primary hypothesis (Aim 1, H3): lower baseline ORMIz predicts greater refeeding intensity, including higher caloric load and more refeeding complications such as edema and electrolyte shifts. This is the endpoint on which the study is powered.","From hospital admission to medical stability, up to 4 weeks",[57,61],{"measure":58,"description":59,"timeFrame":60},"Baseline ORMIz and severity of malnutrition, medical instability, hypometabolism, and pre-admission energy imbalance","Association of baseline organ residual mass index z-score (ORMIz) with (a) markers of malnutrition (body composition, grip strength, Nutrition Risk Score), medical instability (vital signs, organ function, cardiac mass), and hypometabolism (resting energy expenditure and hormonal markers) (Aim 1, H1); and (b) pre-admission energy imbalance (intake minus expenditure), evaluated independent of BMI (Aim 1, H2).","Baseline (hospital admission)",{"measure":62,"description":63,"timeFrame":64},"Change in body composition during refeeding and medical\u002Fmetabolic recovery","Change in organ residual mass (ORM), fat-free mass, and fat mass from admission through refeeding, and its association with improvement in medical stability (H1) and hypometabolism (H2), plus the relationship of ORM change to lower baseline fat mass (H3) (Aim 2).","From hospital admission to post-refeeding assessment, up to 4 weeks","ALL","15 Years","26 Years",{"inclusion":69,"exclusion":74,"raw_text":79},[70,71,72,73],"Diagnosis of anorexia nervosa (AN) or atypical anorexia nervosa (AAN), restricting or purging subtype, per DSM-5","Age 15 to 26 years","Medical instability warranting an inpatient hospitalization defined by either:","Extreme AN is defined as BMI below 15 kg\u002Fm2 or serious medical complications warranting admission to ACUTE (Denver Site).",[75,76,77,78],"Bulimia nervosa","Another primary diagnosis causing malnutrition (not an eating disorder)","Current active suicidality","Metal implants or devices that interfere with study procedures","Inclusion Criteria:\n\n* Diagnosis of anorexia nervosa (AN) or atypical anorexia nervosa (AAN), restricting or purging subtype, per DSM-5\n* Age 15 to 26 years\n* Medical instability warranting an inpatient hospitalization defined by either:\n\n  1. vital signs: daytime heart rate below 50 bpm or nighttime heart rate below 45 bpm, blood pressure below 90\u002F50 mm Hg, temperature below 36 C, orthostatic increase in heart rate above 20 bpm or decrease in systolic blood pressure above 20 mm Hg or decrease in diastolic blood pressure above 10 mm Hg from lying to standing, or median BMI below 75 percent; or\n  2. laboratory abnormality: AST above 40 IU\u002FL, ALT above 30 IU\u002FL, estimated GFR below 90 or cystatin C below 0.7 mg\u002FL, albumin below 3.7 g\u002FdL, or prealbumin below 20 mg\u002FdL\n* Extreme AN is defined as BMI below 15 kg\u002Fm2 or serious medical complications warranting admission to ACUTE (Denver Site).\n\nExclusion Criteria:\n\n* Bulimia nervosa\n* Another primary diagnosis causing malnutrition (not an eating disorder)\n* Current active suicidality\n* Metal implants or devices that interfere with study procedures",[81,82],"CHILD","ADULT",[84,105],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":102},"University of California, San Francisco Benioff Children's Hospital","San Francisco","California","94158","United States",[91,96,100],{"name":92,"role":93,"phone":94,"email":95},"Andrea K Garber, PhD, RD","CONTACT","415-514-2180","andrea.garber@ucsf.edu",{"name":97,"role":93,"phone":98,"email":99},"Arjun S Mehta, MPH","415-476-8195","arjun.mehta@ucsf.edu",{"name":92,"role":101},"PRINCIPAL_INVESTIGATOR",{"lat":103,"lon":104},37.77493,-122.41942,{"facility":106,"city":107,"state":108,"zip":109,"country":89,"contacts":110,"geoPoint":121},"ACUTE Center for Eating Disorders and Malnutrition at Denver Health","Denver","Colorado","80204",[111,115,119],{"name":112,"role":93,"phone":113,"email":114},"Judy Oakes, PhD","303-602-5093","judy.oakes@dhha.org",{"name":116,"role":93,"phone":117,"email":118},"Marina Foster, BA","303-602-1913","marina.foster@dhha.org",{"name":112,"role":120},"SUB_INVESTIGATOR",{"lat":122,"lon":123},39.73915,-104.9847,[125,126],{"name":92,"role":93,"phone":94,"email":95},{"name":97,"role":93,"phone":98,"email":99},[128],{"name":92,"affiliation":12,"role":101},[],[],{"nct_id":4,"conditions":132,"biomarkers":134},[19,133],"Atypical anorexia nervosa",[],{"nct_id":4,"found":136,"summary":137,"prompt_version":147},true,{"design":138,"status":139,"heading":140,"summary":141,"follow_up":142,"word_count":143,"commitments":144,"compensation":145,"drugs_mentioned":146},"This is an observational study, meaning researchers will collect information without giving any specific treatments. It plans to include 90 participants.","completed","3-Dimensional Optical Scanning for Malnutrition in Eating Disorders","This study, called 3D-ED, is looking at new ways to understand and treat malnutrition in young people with anorexia nervosa (AN) or atypical anorexia nervosa (AAN). Instead of just using body weight, researchers will use a special infrared scanner to measure body composition (how much fat and muscle you have) while you are in the hospital. They want to see how these measurements relate to how much nutrition you need, how well you recover in the hospital, and your recovery over the next year. The goal is to create more personalized treatment plans to help people with eating disorders get better. You may be able to join if you are 15-26 years old, have AN or AAN, and need to be hospitalized due to medical instability. The study is currently unclear on its recruitment status.","Researchers will look at recovery outcomes over the year following hospitalization.",135,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]