HealthyMetabolomicsNCT01209884
Metabolomics of Aging: Sub-study of the Healthy Elderly Active Longevity (HEAL) Study
An observational study of Healthy, run by Scripps Translational Science Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 to 85 years
- Men only
- Healthy volunteers accepted
- Older adult
Study population: General outpatient and community population
Who may be able to join
- 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
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- 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)
- Basal or Squamous Cell Carcinoma
- Individuals will be excluded if ANY of the following conditions apply:
Who cannot join
- 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
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- 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
- Anti-platelet or anticoagulant agents, not including Aspirin (ex. Clopidogrel/Plavix, Dipyridamole/Aggrenox/Persantine, Ticlopidine/Ticlid, Warfarin/Coumadin, Plasugrel, etc.)
- Cholinesterase inhibitor for Alzheimer's disease (i.e. Donzepril/Aricept)
- Insulin or oral diabetic medication
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Translational Science Institute
La Jolla, California, 92037
About this study
Official title: Metabolomics of Aging: Sub-study of the Healthy Elderly Active Longevity (HEAL) Cohort
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.
Read the detailed description
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.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Elderly sub-group | Healthy males between the age of 80-85 years old who have not experienced chronic disease during their lifetime. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the metabolomics of the healthy aging
Measured: December 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Topol, MD, Scripps Translational Science Institute
- Investigators
- Eric E Topol, MD, Principal investigator, Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209884
- Sponsor's protocol ID
- SIRB# 10-5416
- Acronym
- Metabolomics
- Status last verified
- Jan 2014
- First submitted
- 24 Sep 2010
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics of Aging: Sub-study of the Healthy Elderly Active Longevity (HEAL) Cohort
- ClinicalTrials.gov ID
- NCT01209884
- Acronym / sponsor ID
- Metabolomics / SIRB# 10-5416
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Elderly sub-group | – | –Healthy males between the age of 80-85 years old who have not experienced chronic disease during their lifetime. |
Who may qualify
- Ages
- 80 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- General outpatient and community population
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (19 listed)
- 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"
- Currently taking any of the following medications on a regular basis:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study the metabolomics of the healthy aging
Time frame: December 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric E Topol, MD principal investigator
Scripps Translational Science Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the metabolomics of the healthy aging (time frame: December 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.