A Natural History Study of Metabolic Sizing in Health and Disease

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · May 31, 2022

Keywords

ClinConnect Summary

This clinical trial, called a natural history study, is looking to better understand how our bodies use energy from food, which is known as metabolism. Researchers believe that the traditional methods for estimating how much energy we use may not be accurate for everyone. By studying a diverse group of people, including healthy individuals and those with conditions like diabetes, obesity, cancer, or kidney disease, the goal is to find more precise ways to measure metabolism and how it relates to body composition.

To participate, individuals must be at least 2 years old and in good health, or have a medical condition that affects metabolism. During the study, participants will spend two days and one night in the hospital, where they will answer questions about their health and lifestyle, follow a special diet, and undergo various tests to measure their metabolism and body composition. These tests include breath analysis, body scanning, and strength assessments. Participants may be invited to return for additional visits throughout the year. This study is important as it aims to improve our understanding of metabolism, which could help in managing various health conditions.

Gender

ALL

Eligibility 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.