Metabolic DisordersNCT05398783
A Natural History Study of Metabolic Sizing in Health and Disease
An observational study of Metabolic Disorders and Cancer, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disorders, Cancer, Chronic Kidney Disease
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2022to 1 Jul 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Local population, primary clinical, referred patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
- Conditions
- Metabolic Disorders, Cancer, Chronic Kidney Disease, Diabetes, Normal Physiology
- Keywords
- Body Composition, Metabolism, Body Surface Area, Natural History
- Medical subject headings
- Metabolic Diseases, Neoplasms, Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in R^2
Increase in R2 when measured BSA is added to equations predicting REE
Measured: 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
Measured: Per study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start25 Oct 2022
- Primary completion1 Jul 2031 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kong Y Chen, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398783
- Sponsor's protocol ID
- 10000617
- Other IDs
- 000617-DK
- Status last verified
- 22 Oct 2026
- First submitted
- 27 May 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Natural History Study of Metabolic Sizing in Health and Disease
- ClinicalTrials.gov ID
- NCT05398783
- Acronym / sponsor ID
- 10000617
- Conditions
- Metabolic Disorders, Cancer, Chronic Kidney Disease, Diabetes, Normal Physiology
- Keywords
- Body Composition, Metabolism, Body Surface Area, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 1 Jul 2031 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Local population, primary clinical, referred patients
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Increase in R^2
Time frame: Per study visit
Increase in R2 when measured BSA is added to equations predicting REE
Mean difference and limits of agreement between measured and predicted BSA
Time frame: Per study visit
Mean difference and limits of agreement between measured BSA and predicted BSA calculated from traditional biometrics such as height and weight
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Derived from this study: PubMed 41230818Ishihara 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kong Y Chen, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Disorders and Cancer, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret S McGehee, C.R.N.P. ((301) 594-6799, mcgeheems@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in R^2 (time frame: Per study visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05398783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.