A Natural History Study of Metabolic Sizing in Health and Disease
2 other identifiers
observational
2,000
1 country
1
Brief Summary
Background: Scientists have long used simple measures (such as height and weight) to estimate how much a person s body uses food (calories) as energy, as commonly called the metabolic rate. But metabolism varies among people with similar body sizes. Scientists now believe the old formulas for estimating metabolic rates may not work well for all people. Researchers want to find more accurate ways to measure a person s metabolism. Objective: This natural history study will examine the relationships between metabolism, body composition, and body surface area in a wide range of people. Eligibility: Healthy children and adults aged 2 years or older. Also, people aged 2 years or older with conditions that may alter metabolism. These may include diabetes, obesity, renal disease, or cancer. Design: Participants will spend 2 days and 1 night in the hospital. They will provide a medical history and answer questions about their activity levels, the foods they eat, and their lifestyle. They will also eat a special diet. Participants will undergo many tests: They will lie in a bed with a clear hood covering their head for 30 to 45 minutes to measure the gases in their breath. They will lie on a padded table for about 15 minutes while their body is scanned. They will stand on a platform while a 3D scanner measures their body. They will have a test to measure how fast an electric signal moves through their body. They will grip an instrument to measure the strength of their hands. They will drink salty water and provide blood and urine samples. Participants may be invited to return for these 2-day visits up to 8 times per year. Return visits must be at least 2 weeks apart.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
October 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2031
May 5, 2026
April 29, 2026
8.7 years
May 27, 2022
May 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Increase in R^2
Increase in R2 when measured BSA is added to equations predicting REE
Per study visit
Mean difference and limits of agreement between measured and predicted BSA
Mean difference and limits of agreement between measured BSA and predicted BSA calculated from traditional biometrics such as height and weight
Per study visit
Study Arms (2)
Healthy Volunteers
Male and female volunteers aged 2+ years in good general health as evidenced by medical history
Patients
Male and female patients aged 2+ years diagnosed with diseases thought to alter metabolism or body composition and/or taking medication thought to alter metabolism or body composition
Eligibility Criteria
Local population, primary clinical, referred patients
You may qualify if:
- In order to be eligible to participate in this study, an individual must meet all the following criteria for their cohort:
- Cohort 1 - Healthy Volunteers
- Male or female, aged \>=2 years
- In good general health as evidenced by medical history
- Cohort 2 - Patients
- Male or female, aged \>=2 years
- Diagnosed with diseases thought to alter metabolism or body composition (such as weight loss or gain, diabetes, renal disease, obesity, cancer, etc.) or taking medications thought to alter metabolism or body composition.
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Participants over 200 kg due to the weight limit of the equipment.
- Presence of any implanted device that would interfere with measurements.
- Any moderate to severe limitations in mobility that would impede participation
- Hemoglobin less than 10 g/dL (in participants who would have blood drawn for research purposes)
- Participants with dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.
- Participants unwilling or unable to give informed consent.
- Participants with any other significant physical, medical, or psychiatric limitations, illness or conditions that may preclude them from completing the majority of the tests in this study per the discretion of the PI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (1)
Ishihara A, Brychta RJ, LaMunion SR, McGehee S, Donayre M, Jordan O, Davis K, Sanchez G, Smith L, Chung ST, Courville AB, Chen KY. Performance of wearable light sensors for measuring photopic and melanopic illuminance under laboratory and free-living conditions. Sleep. 2026 Feb 10;49(2):zsaf358. doi: 10.1093/sleep/zsaf358.
PMID: 41230818DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kong Y Chen, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2022
First Posted
June 1, 2022
Study Start
October 25, 2022
Primary Completion (Estimated)
July 1, 2031
Study Completion (Estimated)
July 1, 2031
Last Updated
May 5, 2026
Record last verified: 2026-04-29