A Natural History Study of Metabolic Sizing in Health and Disease

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT05398783
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 99 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Oct 25, 2022
Status verified
May 2026
Primary completion
Jul 1, 2031
Completion
Jul 1, 2031

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: Healthy Volunteers
    Male and female volunteers aged 2+ years in good general health as evidenced by medical history
  • Arm: 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

Primary Outcome Measure

Increase in R^2 [ Time Frame: Per study visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Bethesda, MD

By condition
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By specialty
NephrologyKidney disease
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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