RECRUITING

A Natural History Study of Metabolic Sizing in Health and Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Natural History Study of Metabolic Sizing in Health and Disease

Quick Facts

Study Start:2022-10-25
Study Completion:2031-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05398783

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, aged \>=2 years
  2. * In good general health as evidenced by medical history
  3. * Male or female, aged \>=2 years
  4. * 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.
  1. * Participants over 200 kg due to the weight limit of the equipment.
  2. * Presence of any implanted device that would interfere with measurements.
  3. * Any moderate to severe limitations in mobility that would impede participation
  4. * Hemoglobin less than 10 g/dL (in participants who would have blood drawn for research purposes)
  5. * Participants with dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.
  6. * Participants unwilling or unable to give informed consent.
  7. * 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.

Contacts and Locations

Study Contact

Margaret S McGehee, C.R.N.P.
CONTACT
(301) 594-6799
mcgeheems@mail.nih.gov
Kong Y Chen, Ph.D.
CONTACT
(301) 451-1636
chenkong@niddk.nih.gov

Principal Investigator

Kong Y Chen, Ph.D.
PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Kong Y Chen, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-25
Study Completion Date2031-07-01

Study Record Updates

Study Start Date2022-10-25
Study Completion Date2031-07-01

Terms related to this study

Keywords Provided by Researchers

  • Body Composition
  • Metabolism
  • Body Surface Area
  • Natural History

Additional Relevant MeSH Terms

  • Metabolic Disorders
  • Cancer
  • Chronic Kidney Disease
  • Diabetes
  • Normal Physiology