Examining how metabolism relates to body composition and size
A Natural History Study of Metabolic Sizing in Health and Disease
This study is testing how metabolism connects to body size and composition in both healthy people and those with metabolic disorders to see if more accurate measurements can improve our understanding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 2 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05398783 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationships between resting energy expenditure, body composition, and body surface area in both healthy individuals and those with metabolic disorders. Participants, aged 2 years and older, will spend two days and one night in the hospital, where they will provide medical histories and answer questions about their lifestyle and dietary habits. The study will compare traditional methods of estimating body surface area with more accurate measurements to better understand metabolism across different populations.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals and those aged 2 years or older with conditions that may alter metabolism, such as diabetes, obesity, renal disease, or cancer.
Not a fit: Patients with severe mobility limitations or those with implanted devices that interfere with measurements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of metabolism, improving treatment strategies for various metabolic disorders.
How similar studies have performed: While the approach of measuring metabolism in relation to body composition is established, this study seeks to refine existing methods, indicating a novel aspect in its methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Kong Y Chen, Ph.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Margaret S McGehee, C.R.N.P.
- Email: mcgeheems@mail.nih.gov
- Phone: (301) 594-6799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.