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

NCT01209884 | Completed

• 1 other identifier: SIRB# 10-5416
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to learn more about healthy aging. We hope to learn which bodily processes or functions are important for the elderly to maintain good health. Metabolites (for example, glucose) are small molecules in our bodies that are used in all bodily reactions. Looking at their levels in healthy elderly people may help researchers find out which processes lead some people to get to disease and others to not. Metabolites are the basic building blocks for people. They are used to construct larger complexes(such as proteins), relay signals from one part of the body to another, and as a source of energy. While most people have essentially the same types of metabolites, the relative levels of these metabolites vary from one individual to another. These levels reflect the body's state of growth, development, and reproduction. An appropriate balance in metabolites is important to maintaining general health. Conditions like cancer and diabetes result in disrupted levels of metabolites that are associated with changes in bodily functions. Deviations from normal levels of metabolites can be used as a signature for disease. Researchers have discovered that a disruption in unique metabolite levels is associated with human aging. In this study we hope to learn which, if any, of these disruptions are associated with the onset of age-related disease.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Study the metabolomics of the healthy aging

  December 2013

Study Arms (1)

Healthy Elderly sub-group

Healthy males between the age of 80-85 years old who have not experienced chronic disease during their lifetime.

Eligibility Criteria

• Age: 80 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General outpatient and community population

You may qualify if:

• Age 80 to 85 years
• Gender: Male
• Enrolled in the Healthy Elderly (HEAL) study prior to enrollment in this sub-study
• Eligible for Blood draw
• Be reliable, cooperative and willing to comply with all protocol-specified procedures.
• Able to understand and grant informed consent
• Be healthy or have mild medical conditions that may be associated with the normal aging process, including:
• Hypertension, well controlled with no more than 3 medications
• Osteoporosis or Osteopenia
• Osteoarthritis
• Benign Prostatic Hypertrophy
• Cataracts, Glaucoma or Macular Degeneration
• Dyslipidemia
• Hypothyroidism
• Pre-Diabetes/Impaired Fasting Glucose (fasting blood glucose 100-126 mg/dL, if known)

You may not qualify if:

• Less than 80 years of age or greater than 85 years of age
• Gender: Female
• Currently undergoing treatment with any investigational agents or devices within 30 preceding enrollment in this study.
• Self-reported history or current diagnosis of significant chronic conditions including"
• Any Cancer (including polycythemia; excluding basal or squamous cell carcinoma
• Coronary Artery Disease, Myocardial Infarction
• Stroke or Transient Ischemic Attack (TIA)
• Deep Vein Thrombosis or Pulmonary Embolism
• Chronis Renal Disease or Hemodialysis
• Significant Auto-Immune or Inflammatory conditions such as Rheumatoid Arthritis, Lupus, Crohn's Disease, etc.
• Alzheimer's or Parkinson's Disease
• Diabetes (Hemoglobin A1C \> 6.5% or fasting glucose \> 126 mg/dL or is treated with insulin or oral diabetic medication
• Aortic or Cerebral Aneurysm
• Currently taking any of the following medications on a regular basis:
• Chemotherapeutic agents (ex. Tamoxifen, Doxorubicin, Mitoxantrone, bleomycin

Sponsors & Collaborators

• Scripps Translational Science Institute: lead

Study Sites (1)

Scripps Translational Science Institute

La Jolla, California, 92037, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample will be collected from each subject after informed consent is obtained Blood collection Approximately 10mL of blood will be collected. The blood will be collected for the purpose of isolating plasma, as follows: 1 X 10mls Sodium (Na) Heparin tube Blood will be drawn by hospital/clinic phlebotomy services, a nurse or a medical assistant. Blood will be collected from each subject one time. Once aliquoted, the plasma will be catalogued in a central registry (LIMS database) and then stored. Metabolite extraction and protein precipitation will be performed to remove proteins and extract the maximum number of metabolites. The samples will be maintained at 4 degrees Celcius in the autosampler and then analyzed.

Study Officials

• Eric E Topol, MD

  Scripps Translational Science Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 27, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 9, 2014

Record last verified: 2014-01

Locations

US (1)