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Набор скоро начнётся NCT07726524

3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study

Наблюдательное Anorexia in Adolescence Anorexia Nervosa Anorexia Nervosa, Atypical Anorexia Nervosa, Binge Eating/Purging Type

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Anorexia in Adolescence, Anorexia Nervosa, Anorexia Nervosa, Atypical, Anorexia Nervosa, Binge Eating/Purging Type. Базовые параметры: 15 лет — 26 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Refeeding intensity: caloric load to achieve medical stability (predicted by baseline ORMIz) [Срок оценки: From hospital admission to medical stability, up to 4 weeks]
Вторичные конечные точки (2)
  • Baseline ORMIz and severity of malnutrition, medical instability, hypometabolism, and pre-admission energy imbalance [Срок оценки: Baseline (hospital admission)]
  • Change in body composition during refeeding and medical/metabolic recovery [Срок оценки: From hospital admission to post-refeeding assessment, up to 4 weeks]

Критерии участия

Критерии включения

  • 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:
  • 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
  • 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).

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 2 центра
  • University of California, San Francisco Benioff Children's Hospital — San Francisco
  • ACUTE Center for Eating Disorders and Malnutrition at Denver Health — Denver

Идентификаторы

NCT: NCT07726524 · 1R01HD119553-01A1 · 26-46188 · R01HD119553

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗