| NCT ID | NCT03366168 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute on Aging (NIA) |
| Condition | Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2017-12-18 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Background: Stem cells are found in body tissues. They can regenerate into more of the same cells or become other types of cell. Researchers want to use stem cells from taste buds to try to make cells that secrete insulin. Taste buds are found mostly on the tip and sides of the tongue. Researchers also want to study if the number of taste buds and stem cells decrease as people age. They will remove small pieces of tongue tissue (about the size of a pen tip). The taste buds will grow back. It is hoped that studying taste bud stem cells can lead to new diabetes treatments. Objectives: To see if stem cells from taste buds can be isolated in humans. Eligibility: Healthy adults at least 18 years old Design: Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Tongue photograph and mouth inspection. Food coloring will be applied to the tongue. Participants will have 1 study visit. They will not eat or drink anything 8 hours before. * They will give blood and urine samples. * They will have a tongue biopsy. Vital signs will be checked. The inside of the mouth will be examined. The tongue may be cleaned. The tongue will be numbed. Five small pieces of tissue will be taken with a small scissor. Any bleeding will be blotted with cotton and should stop in minutes. * Participants will be monitored for about 30 minutes. They will get a snack or meal. * They will be told how to take care of the tongue for the rest of the day. Participants will be called a week later to see how the ...
Eligibility Criteria
* INCLUSION CRITERIA: * Age 18 years and older * Healthy (see exclusion criteria below) * Are able to understand the study risks and procedures, and consent to participate in the study. * Are able to read and speak English. EXCLUSION CRITERIA: * Have less than 40 fungiform papillae on the anterior third portion of the tongue as evidenced by tongue photo taken during the screen visit. * Does not agree to the use of their tissue samples to produce stem cells. * A medical condition that requires the use of chronic anticoagulant medication use such as warfarin, clopidogrel, heparin or antiplatelet agents other than low dose aspirin (81mg). * History of increased bleeding due to either a known medical condition or an undiagnosed cause. * Active infections or chronic conditions that would prevent access to the biopsy area. * Taking non-steroidal anti-inflammatory agents (NSAIDs) such as Motrin (Ibuprofen), Advil (Ibuprofen) or Naprosyn (Naproxen) and the participant is unable to stop taking
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