| 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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2017-12-18 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 them 4 days before and 3 days after the final biopsy procedure. * Taking more than 81 mg of aspirin a day and the participant is unable to stop taking it for 4 days before and 3 days after the biopsy procedure. * Allergic to Lidocaine (Xylocaine) or any other local anesthetic or the participant has had in the past a severe allergic reaction to similar drugs. * Have taken steroids, other than ocular within 30 days of their scheduled biopsy procedure. * HIV virus infection. * Hepatitis B or C. * Kidney disease (Creatinine greater than1.5 mg/dl or calculated creatinine clearance less than 50 cc/min). * Liver disease (ALT, AST or alkaline phosphatase twice the normal serum concentration). * Severe gastrointestinal diseases such as Crohn s disease or ulcerative colitis requiring continuous treatment. * History of severe pulmonary disease such as chronic obstructive pulmonary disease (COPD) or asthma requiring continuous medication use. * History of using any tobacco products within the past six months. * History of severe psychiatric conditions associated with behavioral problems or requiring chronic medical treatment. * Currently pregnant or breastfeeding. * Current illness that as judged by the study physician substantially increases the risks associated with the tongue biopsy (active infections, allergies, etc.).
Contact & Investigator
Josephine M Egan, M.D.
PRINCIPAL INVESTIGATOR
National Institute on Aging (NIA)
Frequently Asked Questions
Who can join the NCT03366168 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03366168 currently recruiting?
Yes, NCT03366168 is actively recruiting participants. Contact the research team at melvinde@mail.nih.gov for enrollment information.
Where is the NCT03366168 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT03366168 clinical trial?
NCT03366168 is sponsored by National Institute on Aging (NIA). The principal investigator is Josephine M Egan, M.D. at National Institute on Aging (NIA). The trial plans to enroll 250 participants.
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