A Natural History Study of Metabolic Sizing in Health and Disease

Recruiting

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

• Registration Number: NCT05398783
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

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 Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-01
• Study Start: 2022-10-25
• Status Verified: 2025-03-21
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2031-07-01
• Study Completion: 2031-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean difference and limits of agreement between measured and predicted BSA	Per study visit	Mean difference and limits of agreement between measured BSA and predicted BSA calculated from traditional biometrics such as height and weight
Increase in R^2	Per study visit	Increase in R2 when measured BSA is added to equations predicting REE

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States