Summary

Eligibility
for people ages 15-26 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Andrea K Garber, PhD, RD
Headshot of Andrea K Garber
Andrea K Garber

Description

Summary

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.

Details

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.

Aim 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.

Aim 2) Monitor response to refeeding in hospital. Change in ORM will correlate with: H1) medical stability, H2) metabolic stability, and H3) lower baseline FM.

Aim 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.

Keywords

Anorexia in Adolescence, Anorexia Nervosa, Anorexia Nervosa, Atypical, Anorexia Nervosa, Binge Eating/Purging Type, Anorexia Nervosa Restricting Type, Anorexia Nervosa With Significantly Low Body Weight, Body Composition Changes, Growth & Development, Malnutrition Severe, Malnutrition, Calorie, 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, Growth charts, Bulimia, Malnutrition, Feeding and Eating Disorders

Eligibility

You can join if…

Open to people ages 15-26

  • 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:
    1. vital signs: daytime heart rate below 50 bpm or nighttime heart rate below 45 bpm, blood pressure below 90/50 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
    2. laboratory abnormality: AST above 40 IU/L, ALT above 30 IU/L, estimated GFR below 90 or cystatin C below 0.7 mg/L, albumin below 3.7 g/dL, or prealbumin below 20 mg/dL
  • Extreme AN is defined as BMI below 15 kg/m2 or serious medical complications warranting admission to ACUTE (Denver Site).

You CAN'T join if...

  • Bulimia nervosa
  • Another primary diagnosis causing malnutrition (not an eating disorder)
  • Current active suicidality
  • Metal implants or devices that interfere with study procedures

Locations

  • UCSF Benioff Children's Hospital
    San Francisco California 94158 United States
  • ACUTE Center for Eating Disorders and Malnutrition at Denver Health
    Denver Colorado 80204 United States

Lead Scientist at UCSF

  • Andrea K Garber, PhD, RD
    Dr. Garber is a Professor of Pediatrics in the Division of Adolescent Medicine at the University of California, San Francisco (UCSF). She is a nutritionist, with a PhD in Human and Clinical Nutrition from the University of Wisconsin-Madison, and a Registered Dietitian (RD) from UCSF. She is the Chief Nutritionist for the UCSF Eating Disorders Program.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07726524
Study Type
Observational
Participants
Expecting 90 study participants
Last Updated