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Metabolomics of Aging: Sub-study of the Healthy Elderly Active Longevity (HEAL) Cohort


N/A
80 Years
85 Years
Open (Enrolling)
Male
Healthy

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Trial Information

Metabolomics of Aging: Sub-study of the Healthy Elderly Active Longevity (HEAL) Cohort


The HEAL study criteria includes subjects who are 80 years of age and older who have not
experienced a chronic condition. This sub-study will use plasma samples of up to 100 HEAL
subjects to compare the metabolomic findings found within this group with existing young
and elderly plasma samples that are currently under analysis at the Siuzdak lab.

The aim of this sub-study is to determine if metabolites that are downregulated in elderly
relative to young individuals are similarly downregulated in the Wellderly.

Metabolomics is a rapidly emerging field focused on profiling small, naturally occurring
(endogenous) molecules collectively known as the "metabolome." Metabolomics offers a
significant advantage over other "omics" sciences (e.g., transcriptomics and proteomics) in
that metabolites represent the most

downstream end products of cellular reactions and therefore most closely correlate with the
phenotype. Thus, by comparative untargeted profiling, metabolomics provides a powerful
strategy for understanding changes associated with a unique phenotype at the molecular
level.

Untargeted metabolomics denotes the profiling of all low molecular weight biochemicals,
including lipids, hormones, saccharides, nucleotides, organic acids, and amino acids that
serve as substrates and products in metabolic pathways. The analytes are measured without
specifically "targeting" distinct metabolites or molecules. Untargeted metabolomics has the
capacity to implicate unanticipated metabolites or pathways associated with a unique
phenotype (i.e., advanced age), and thereby provide great insight into cellular mechanisms
and pathobiology. In the latter context, the Siuzdak Laboratory has pioneered a new
approach for investigating disease known as therapeutic metabolomics in which cellular
pathways associated with disease are identified and then perturbed.

Inclusion Criteria


INCLUSION CRITERIA

1. Age 80 to 85 years

2. Gender: Male

3. Enrolled in the Healthy Elderly (HEAL) study prior to enrollment in this sub-study

4. Eligible for Blood draw

5. Be reliable, cooperative and willing to comply with all protocol-specified
procedures.

6. Able to understand and grant informed consent

7. Be healthy or have mild medical conditions that may be associated with the normal
aging process, including:

1. Hypertension, well controlled with no more than 3 medications

2. Osteoporosis or Osteopenia

3. Osteoarthritis

4. Benign Prostatic Hypertrophy

5. Cataracts, Glaucoma or Macular Degeneration

6. Dyslipidemia

7. Hypothyroidism

8. Pre-Diabetes/Impaired Fasting Glucose (fasting blood glucose 100-126 mg/dL, if
known)

9. Basal or Squamous Cell Carcinoma

Individuals will be excluded if ANY of the following conditions apply:

EXCLUSION CRITERIA

1. Less than 80 years of age or greater than 85 years of age

2. Gender: Female

3. Currently undergoing treatment with any investigational agents or devices within 30
preceding enrollment in this study.

4. Self-reported history or current diagnosis of significant chronic conditions
including"

1. Any Cancer (including polycythemia; excluding basal or squamous cell carcinoma

2. Coronary Artery Disease, Myocardial Infarction

3. Stroke or Transient Ischemic Attack (TIA)

4. Deep Vein Thrombosis or Pulmonary Embolism

5. Chronis Renal Disease or Hemodialysis

6. Significant Auto-Immune or Inflammatory conditions such as Rheumatoid Arthritis,
Lupus, Crohn's Disease, etc.

7. Alzheimer's or Parkinson's Disease

8. Diabetes (Hemoglobin A1C > 6.5% or fasting glucose > 126 mg/dL or is treated
with insulin or oral diabetic medication

9. Aortic or Cerebral Aneurysm

5. Currently taking any of the following medications on a regular basis:

1. Chemotherapeutic agents (ex. Tamoxifen, Doxorubicin, Mitoxantrone, bleomycin

2. Anti-platelet or anticoagulant agents, not including Aspirin (ex.
Clopidogrel/Plavix, Dipyridamole/Aggrenox/Persantine, Ticlopidine/Ticlid,
Warfarin/Coumadin, Plasugrel, etc.)

3. Cholinesterase inhibitor for Alzheimer's disease (i.e. Donzepril/Aricept)

4. Insulin or oral diabetic medication

6. Individual has a significant medical condition which, in the investigator's opinion,
may interfere with the individual's optimal participation in the study or would
potentially confound interpretation of the individual's phenotype.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Eric E Topol, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Scripps Translational Science Institute

Authority:

United States: Institutional Review Board

Study ID:

SIRB# 10-5416

NCT ID:

NCT01209884

Start Date:

February 2010

Completion Date:

February 2030

Related Keywords:

  • Healthy

Name

Location

Scripps Translational Science Institute La Jolla, California  92037