A Natural History Study of Metabolic Sizing in Health and Disease

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Overall Status

Not yet recruiting

CT.gov ID

NCT05398783

Collaborator

(none)

2,000

Enrollment

Location

106

Anticipated Duration (Months)

18.9

Patients Per Site Per Month

Study Details

Study Description

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 10 years or older. Also, people aged 10 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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Disorders Cancer Chronic Kidney Disease Diabetes Normal Physiology

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

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

A Natural History Study of Metabolic Sizing in Health and Disease

Anticipated Study Start Date :

Aug 30, 2022

Anticipated Primary Completion Date :

Jul 1, 2031

Anticipated Study Completion Date :

Jul 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Healthy Volunteers Male and female volunteers aged 10+ years in good general health as evidenced by medical history
Patients Male and female patients aged 10+ years diagnosed with diseases thought to alter metabolism or body composition and/or taking medication thought to alter metabolism or body composition

Outcome Measures

Primary Outcome Measures

Increase in R^2 [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 [Per study visit]
Mean difference and limits of agreement between measured BSA and predicted BSA calculated from traditional biometrics such as height and weight

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 >=10 years
In good general health as evidenced by medical history

Cohort 2 - Patients

Male or female, aged >=10 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.
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.