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RecruitingNCT05398783Updated Oct 6, 2026

A Natural History Study of Metabolic Sizing in Health and Disease

An observational study in Metabolic Disorders, Cancer and Chronic Kidney Disease, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruiting at 1 site in United States. Open to participants aged 2 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational

From the registry’s dates

  • Started Oct 2022; still recruiting 3 years 11 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,000
Ages
2 Years to 99 Years
Sex
All
01

Study 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.

Read the detailed description

Study Description:

This study will examine the relationships between comprehensively measured resting energy expenditure (REE), body composition, and body surface area (BSA) in a wide range of healthy and diseased individuals.

Objectives:

Primary Objectives:

  • To compare estimated and measured BSA.
  • To determine if measured BSA is associated with REE independent of body composition measures

Endpoints:

Primary Endpoints:

  • Mean difference and limits of agreement at baseline between measured BSA and predicted BSA calculated from traditional biometrics such as height and weight.
  • Increase in R\^2 when measured BSA is added to equations predicting REE.
02

Conditions studied

  • Metabolic Disorders
  • Cancer
  • Chronic Kidney Disease
  • Diabetes
  • Normal Physiology

Keywords

  • Body Composition
  • Metabolism
  • Body Surface Area
  • Natural History
03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 176 across 300 observational studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.

Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Local population, primary clinical, referred patients

Inclusion criteria

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.

Exclusion criteria

EXCLUSION CRITERIA:

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,000 participants (estimated)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Increase in R^2

    Increase in R2 when measured BSA is added to equations predicting REE

    Time frame: Per study visit

  2. 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

    Time frame: Per study visit

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contact · ccopr@nih.gov · 800-411-1222
    Recruiting
08

References and documents

Publications

  • 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. PubMed 41230818 ↗

Individual participant data

Plan to share: Undecided

09

Updates

2 registry updates since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
2 updates, last Oct 6, 2026
Show all 2 updates
  1. Oct 6, 2026
    Minor edits only
    + 1 other change: verification date
  2. Oct 1, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05398783
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Sponsor
First posted
Jun 1, 2022
Start date
Oct 25, 2022
Primary completion
Jul 1, 2031 (estimated)
Completion
Jul 1, 2031 (estimated)
Last update
Oct 6, 2026

Study contacts

Margaret S McGehee, C.R.N.P.
Contact
mcgeheems@mail.nih.gov
(301) 594-6799
Kong Y Chen, Ph.D.
Contact
chenkong@niddk.nih.gov
(301) 451-1636
Kong Y Chen, Ph.D.
principal investigator · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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