RecruitingNot Applicable

Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)

United States900 participantsStarted 2015-03-15

Plain-language summary

Background: \- Biomarkers are substances in people's blood and tissues. They help researchers understand diseases and signs of aging. Scientists want to do more research on biomarkers to find ways to improve quality of life in old age. Objective: \- To learn more about biomarkers and their relationship to aging. Eligibility: \- Adults at least 20 years old who weigh at least 110 pounds and have a body mass index below 30. They must agree that their genetic samples can be collected, studied, and stored. Design: * Participants will be screened with medical history, physical exam, EKG and blood and urine tests. * Participants will have 3-day visits. They will return every 2 years. * All visits include: * Blood and urine collection * Physical performance tests * Health questionnaires * Memory and problem-solving tests * Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT) scans. * Muscle metabolism/ exercise tests * Taste strips * Muscle and/or skin biopsies/ red light therapy * Retinal imaging/ eye tracking * Sleep study * ODD visits also include: * Cytapheresis * Bone marrow aspirate * EVEN visits also include: * Hyperglycemic CLAMP * Lumbar Puncture (LP) * Continuous Glucose Monitor (CGM)

Who can participate

Age range

20 Years – 120 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.

* Since the study of gene expression and epigenetic regulation are essential aims of GESTALT, all participants are required to consent to DNA/RNA testing and storage at all visits. Participants that refuse genetic testing and storage will not be eligible to participate or to continue to participate in the study. The criteria below for each group pertains only to the Screening and Baseline Visits, except where otherwise noted. If any of the conditions develop while the participant is in the study, the participant remains in the study. However, participants that develop severe cognitive problems and are diagnosed by the cognition group with dementia, will no longer be able to participate in the study. INCLUSION CRITERIA for the Healthy Group: * Age \>= 20 years of age. * Are willing to return every 2 years for study visit procedures. * Agree to genetic (DNA/RNA) sample collection, analysis, and storage. * Have good venous access for cytapheresis and are in good health as determined by the Apheresis Health History Questionnaire and are found eligible for apheresis (Apheresis Eligibility form). * Weigh \>= 110lbs and a body mass index (BMI) \< 30. * Do not have established genetic diseases such as sickle cell, hemochromatosis (iron overload), cystic fibrosis or Ehlers-Danlos syndrome (connective tissue disorder). * Do not have autoimmune diseases such as Hashimoto's thyroiditis, Myasthenia Gravis or Rheumatoid arthritis. * Report that they are able to perform daily self- care …

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Development of state-of-theart expression/methylation /protein PBMC atlas in aging

Timeframe: Ongoing

Trial details

NCT IDNCT02339012

SponsorNational Institute on Aging (NIA)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2099-12-31

Contact for this trial

Linda M Zukley, Ph.D.

(410) 350-3983 zukleylm@mail.nih.gov

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