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

NCT02339012 | Recruiting

• 2 other identifiers: 15006315-AG-0063
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Healthy Volunteers; Non-Healthy/Non-Frail; Frail

Keywords

Genome Wide Association; Biomarkers; Methylation; Phenotype; Cytometry; Natural History

Outcome Measures

Primary Outcomes (1)

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

  measurement of epigenetic, gene expression, and protein biomarkers

  Ongoing

Study Arms (3)

Frail

frail individuals ages 50-64 years; 65-79 years; 80+ years

Healthy

healthy individuals ages 20-34 years; 35-39 years; 50-64 years; 65-79 years; 80+ years

Non-Healthy/Non-Frail

non-healthy/non-frail individuals ages 20-34 years; 35-39 years; 50-64 years; 65-79 years; 80+ years

Eligibility Criteria

• Age: 20 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy Volunteers, Non-Healthy/Non-Frail, Frail

You may qualify if:

• Age greater than or equal to 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 greater than or equal to 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 without assistance.
• Report that they able to walk independently for at least 400 meters without assistance and without developing severe symptoms.
• Report they are able to perform normal activities of daily living without shortness of breath (walking or climbing stairs) or other severe symptoms.
• Do not have cognitive impairment based on mental status screening tests and evaluations and in the absence of any drug treatment.
• Do not have a history of cardiovascular disease or cerebrovascular disease including angina (requiring treatment), myocardial infarction, congestive heart failure, uncontrolled hypertension, pacemaker, stroke, or transient ischemic attacks (TIA).
• Do not have a history of diabetes (requiring any medical treatment other than diet and exercise) and their fasting Glucose is \<126 mg/dL.
• Do not have active (any activity in the last 10 years) cancer, except for locally limited squamous and basal cell cancer.
• Do not have a history of neurological diseases or birth defects (other than minor anatomical abnormalities, which do not affect physical and/or cognitive function).

You may not qualify if:

• HIV virus infection (all groups).
• Hepatitis B or C (all groups).
• Active syphilis, gonorrhea or TB requiring treatment (all groups).
• WBC \<3,000 or \> 12,000/k/microL (only Healthy group).
• Platelets \< 100,000 or \>600,000 k/ microL (only Healthy group).
• Hemoglobin \< 11.0 gm/dL in women and \< 12.0 gm/dL in men (only Healthy group).
• GFR \<50 mL/min/1.73 m\^2 (only Healthy group)
• GFR \<= to 30 (only non-Healthy-or-Frail group or Frail group)
• Bilirubin \> 1.5 mg/dl (unless higher levels can be ascribed to Gilbert's disease (only Healthy group).
• ALT, AST, or alkaline phosphatase twice the normal serum concentration (only Healthy group).
• Corrected calcium \< 8.5 or \> 10.7 mg/dl (all groups).
• Albumin \< 3.1 g/dl (only Healthy group).
• Cholesterol, LDL and/or Triglycerides \>1.5x normal (only Healthy group).
• Positive Urine Drug Screen (unless taking prescribed medication and at the discretion of the PI) (all groups).
• Currently pregnant or a nursing mother (all groups).

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Luigi Ferrucci, M.D.

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda M Zukley, Ph.D.

CONTACT

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

Luigi Ferrucci, M.D.

CONTACT

(410) 558-8110; ferruccilu@grc.nia.nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 15, 2015
• Study Start: March 15, 2015
• Primary Completion (Estimated): December 31, 2099
• Study Completion (Estimated): December 31, 2099
• Last Updated: April 24, 2026

Record last verified: 2026-04-03

Locations

US (1)