A Natural History Study of Metabolic Sizing in Health and Disease (NCT05398783) | Clinical Trial Compass
RecruitingNot Applicable
A Natural History Study of Metabolic Sizing in Health and Disease
United States2,000 participantsStarted 2022-10-25
Plain-language 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.
Who can participate
Age range
2 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study seems to be focused on observational data collection rather than any treatment — can you explain what exactly they'd be measuring about my body size and metabolism, and whether participating would involve anything beyond measurements and possibly blood or other samples?
2Since this is a natural history study that includes people with metabolic disorders, cancer, chronic kidney disease, and diabetes all under one umbrella, can you help me understand how my specific condition fits into what researchers are trying to learn here?
3The trial is measuring how well predicted body surface area matches measured body surface area — can you explain why that matters for how I'm currently being treated, and whether any findings from this study could eventually affect my dosing or care?
4Because this is labeled Phase NA, meaning it's not testing a new treatment but rather gathering baseline scientific data, what are the practical risks or burdens of participating, and is there any direct benefit to me or is this purely contributing to future research?
5Are there standard clinical evaluations or treatment decisions for my condition that should come first before I consider joining an observational study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Increase in R^2
Timeframe: Per study visit
2
Mean difference and limits of agreement between measured and predicted BSA
Timeframe: Per study visit
Trial details
NCT IDNCT05398783
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)