A Natural History Study of Metabolic Sizing in Health and Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Cancer; Chronic Kidney Disease; Normal Physiology; Metabolic Disorders

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Margaret S McGehee, C.R.N.P.; Phone Number: (301) 594-6799; Email: mcgeheems@mail.nih.gov
• Study Contact Backup: Name: Kong Y Chen, Ph.D.; Phone Number: (301) 451-1636; Email: chenkong@niddk.nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY dial 711 800-411-1222; Email: ccopr@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Local population, primary clinical, referred patients

Description

• 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:

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Kong Y Chen, Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

General 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 15, 2026

More Information

Terms related to this study

• Keywords: Natural History; Body Composition; Metabolism; Body Surface Area
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Glucose Metabolism Disorders; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Neoplasms; Diabetes Mellitus; Renal Insufficiency, Chronic; Metabolic Diseases
• Other Study ID Numbers: 10000617; 000617-DK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No