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

What Is This Study About?

This long-term study will help researchers learn more about biomarkers in human blood and tissues and their relationship to aging. People who are healthy, frail, or have a medical condition can participate. Participants will take part in a medical history, physical exam, blood and urine tests, and heart tests. There will be a two-day baseline visit, followed by visits every two years for up to 10 years, during which they will repeat screening procedures, including balance and walking tests, leg and grip strength tests, health and mental state questions, and memory and problem-solving tests. Participants will also undergo cytapheresis, a procedure that removes blood through a needle in the vein of one arm, runs it through a machine, then returns it through a needle in a vein of the other arm. Visits may include magnetic resonance imaging (MRI) scans, a diabetes test, and removal of a small amount of muscle tissue and/or skin.

Do I Qualify To Participate in This Study?

Must have:

Healthy Participants

• 20 years of age or older
• Consent to genetic testing and storage at the screening visit and all subsequent visits
• Willingness to return every two years for study visit procedures
• Good vein access for blood sampling
• Eligible for apheresis, a technology in which one's blood is passed through an apparatus that separates one particular constituent and returns the rest to circulation
• Weight of 110 pounds or greater and a body mass index of less than 30
• Able to care for self without assistance
• Able to walk for at least 400 meters without assistance and to perform normal activities of daily living without shortness of breath or other severe symptoms
• Able to read and speak English
• Able to undergo MRI (e.g., not claustrophobic, and do not have metal implants, or hip or knee replacements)

Frail Participants and Non-Healthy Participants

• 20 years of age or older
• Consent to genetic testing and storage at the screening visit and all subsequent visits
• Willingness to return every two years for study visit procedures
• Good vein access for blood sampling
• Weight of 110 pounds or greater and a body mass index of less than 35
• Ability to read and speak English
• Ability to undergo MRI (e.g., not claustrophobic, and do not have metal implants, or hip or knee replacements)

Must NOT have:

Healthy Participants

• Participants who develop cognitive and motor problems from medical conditions can continue in the study but are excluded from tests in which the medical condition is excluded.
• Genetic disease such as sickle cell anemnia, hemochromatosis (iron overload), cystic fibrosis, or Ehlers-Danlos syndrome (connective tissue disorder)
• Autoimmune diseases such as Hashimoto's thyroiditis, myasthenia gravis, or rheumatoid arthritis
• Cognitive impairment or dementia (Mini-Mental State Examination <26 or Blessed Mental >3)
• History of cardiovascular disease or cerebrovascular disease, including angina requiring treatment, myocardial infarction, congestive heart failure, uncontrolled hypertension, pacemaker, stroke, or transient ischemic attack
• History of diabetes requiring medical treatment other than diet and exercise, with fasting glucose level <126 mg/dL
• Cancer within the past 10 years, except for locally limited squamous and basal cell cancer
• Clinically significant hormonal dysfunction; mild hypothyroidism in participants over age 60 is allowed
• History of neurological disease or birth defect (other than minor anatomical abnormalities, which do not affect physical and/or cognitive function)
• History of kidney or liver disease; history of severe gastrointestinal disease requiring chronic treatment (GERD, Crohn's disease, ulcerative colitis); history of severe pulmonary disease (COPD or asthma requiring continuous medication use); muscle-skeletal conditions due to diseases or traumas that cause pathological weakness and/or chronic pain
• History of severe psychiatric conditions associated with behavioral problems or requiring chronic medical treatment
• Medical condition that requires continuous, long-term treatment with antibiotics, corticosteroids, immunosuppressors, H2 blockers and/or proton pump inhibitors, or pain medications, or that requires the use of chronic anticoagulant medication such as Coumadin, heparin, or antiplatelet agents other than low-dose aspirin
• Important sensory deficits that preclude participating in standard neuropsychological tests or providing informed consent
• Pregnant or nursing
• Current smoking or smoking within the past three months
• History of allergy to acid-citrate-dextrose (ACD) anticoagulant or active bleeding disorder such as hemophilia or Von Willebrand disease.
• History of seizures within the last three months
• History of Lyme disease, unless six weeks after treatment and no new symptoms
• HIV virus infection; hepatitis B or C; active syphilis, gonorrhea, or tuberculosis requiring treatment
• Laboratory results outside ranges determined by study leaders; positive urine drug screen (unless taking prescribed medication)

Frail Participants and Non-Healthy Participants

• Genetic disease such as sickle cell anemnia, hemochromatosis (iron overload), cystic fibrosis, or Ehlers-Danlos syndrome (connective tissue disorder)
• Important sensory deficits that preclude participating in standard neuropsychological tests or providing informed consent
• Pregnant or nursing
• Current acute medical condition
• History of active bleeding disorder such as hemophilia or Von Willebrand disease.
• History of seizures within the last three months

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

Maryland
National Institute of Aging, Clinical Research Unit Baltimore, MD 21224 Recruiting NIA Studies Recruitment 410-350-3941 niastudiesrecruitment@mail.nih.gov

Who Sponsors This Study?

Lead: National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT02339012