ObesityPro-MetageNCT06511297
Metabolic Control of Aging and Disease - the MetAGE Deep Phenotyping Cohort
An observational study of Obesity and Aging, run by Thomas Scherer at 2 sites in Austria.
Trial summary
The goal of this prospective observational study is to identify and validate blood based aging biomarkers in relation to cardiometabolic phenotypes of young and old, female and male subjects with or without obesity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Aging, Aging Problems
- What is being tested?
- comprehensive metabolic phenotyping
- How many people
- 650 participants
- Where
- 2 sitesAustria
- Study dates
- 5 May 2025to 1 Jan 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample from eastern Austria.
Who may be able to join
- Group 1 - Lean, young adults (n = 150)
- Age 18 - 35 years
- Body mass index (BMI) ≥ 18.5 and ≤ 24.9 kg/m2 (≥ 12 months)
- Group 2 - Overweight, young adults (n = 150)
- Age 18 - 35 years
- BMI ≥ 28kg/m2 (≥ 12 months)
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- Group 3 - Lean, older adults (n = 150)
- Age ≥ 60 years
- BMI ≥ 18.5 and ≤ 24.9 kg/m2 (≥ 3 years)
- Group 4 - Overweight, older adults (n = 150)
- Age ≥ 60 years
- BMI ≥ 28 kg/m2 (≥ 3 years)
- Subgroup A (n=75): with pre-existent cardiovascular disease defined as: history of myocardial infarction or evidence of coronary artery disease irrespective of revascularization status or history of ischemic or hemorrhagic stroke or presence of peripheral artery disease or heart failure with preserved ejection fraction (NYHA Class I-II).
- Subgroup B (n=75): without pre-existent cardiovascular disease
- Group 5 - Nonagenerians Age ≥ 90 (n = 50)
- Age ≥ 90 years
- BMI ≥ 18.5 kg/m2 (≥ 3 years)
Who cannot join
- Group 1 - Lean, young adults (n = 150)
- Highly physical active (i.e. > 5 times sporting activity / week with moderate to high intensity [heart rate 140 - 200bpm])
- Special diets (i.e. ketogenic diet and time-restricted eating)
- Clinically significant metabolic or endocrine disorders
- Claustrophobia
- drug abuse, alcohol > 15 drinks/week
Show all 43Show fewer
- Heart failure, cardiovascular disease, immunosuppressive therapies, chronic inflammatory diseases and active oncologic conditions
- Metal implants that prohibit 3T MRI
- Pregnancy or breastfeeding
- Group 2 - Overweight, young adults (n = 150)
- Highly physical active (i.e. > 5 times sporting activity / week with moderate to high intensity [heart rate 140 - 200bpm])
- Special diets (i.e. ketogenic diet and time-restricted eating)
- Active anti-obesity treatment (e.g. glucagon-like peptide 1 (GLP-1) analogues, polyagonists, naltrexone and bupropion)
- Clinically significant metabolic or endocrine disorders
- Claustrophobia
- drug abuse, alcohol > 15 drinks/week
- Heart failure, cardiovascular disease, immunosuppressive therapies, chronic inflammatory diseases and active oncologic conditions
- Metal implants that prohibit 3T MRI
- Pregnancy or breastfeeding
- Group 3 - Lean, older adults (n = 150)
- Highly physical active (i.e. > 5 times sporting activity / week with moderate to high intensity [heart rate 140 - 200bpm])
- Special diets (i.e. ketogenic diet and time-restricted eating)
- Diabetes, overt hypo/hyperthyroidism
- Claustrophobia
- drug abuse, alcohol > 15 drinks/week
- Metal implants that prohibit 3T MRI
- Known severe cardiovascular diseases (i.e. PAD IIa or higher, advanced heart failure = left ventricular ejection fraction (LVEF) < 35% or NYHA Class III-IV)
- No previous heart failure, cardiovascular disease, immunosuppressive therapies, chronic inflammatory diseases and active oncologic conditions up until the age of 35 years.
- Life-threatening conditions with a life expectancy of less than 1 year or any other condition that would jeopardize proband safety/adherence while participating in this trial.
- Group 4 - Overweight, older adults (n = 150)
- Special diets (i.e. ketogenic diet and time-restricted eating)
- Diabetes, overt hypo/hyperthyroidism
- Active anti-obesity treatment (e.g. GLP-1 analogues, polyagonists, naltrexone and bupropion)
- Claustrophobia
- drug abuse, alcohol > 15 drinks/week
- Metal implants that prohibit 3T MRI
- No previous heart failure, cardiovascular disease, immunosuppressive therapies, chronic inflammatory diseases and active oncologic conditions up until the age of 35 years.
- Life-threatening conditions with a life expectancy of less than 1 year or any other condition that would jeopardize proband safety/adherence while participating in this trial.
- Group 5 - "healthy" Nonagenerians Age ≥ 90 (n = 50)
- Claustrophobia
- Clinically significant cognitive impairment compromising study adherence
- Metal implants that prohibit 3T MRI
- Life-threatening conditions with a life expectancy of less than 1 year or any other condition that would jeopardize proband safety/adherence while participating in this trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria2 sites, 2 recruiting
- Recruiting
Medical University of Graz
Graz, Styria
Thomas Pieber, MD, Prof., +43 316 385 82383, thomas.pieber@medunigraz.at
- Recruiting
Medical University of Vienna
Vienna, State of Vienna
Thomas Scherer, MD, +43 1 40400 43121, thomas.scherer@meduniwien.ac.at
About this study
Official title: Metabolic Control of Aging and Disease - the MetAGE Deep Phenotyping Cohort (Pro-Metage)
The goal of this prospective observational study is to identify and validate blood based aging biomarkers in relation to cardiometabolic phenotypes of young and old, female and male subjects with or without obesity.
The main question is to gain insights into the interaction of obesity related metabolic alteration and aging, and the relevance of loss of metabolic control in the development of age-related diseases in order to build a foundation for targeted drug- and lifestyle interventions in future studies.
Read the detailed description
The ongoing increase in human life expectancy is steadily reshaping the demographic landscape, leading to a higher proportion of older adults, many of whom suffer from multiple health conditions. These unprecedented demographic shifts come at a significant socioeconomic cost, as aging stands as the primary risk factor for chronic disabilities and disorders such as cardiovascular diseases, dementia, type 2 diabetes, obesity, steatotic liver disease and infections. Consequently, promoting healthy aging emerges as one of the most pressing societal challenges in the foreseeable future, underscoring the urgent need for clinically validated strategies to extend the disease-free phase of life, known as health span.
The Pro-MetAGE prospective cohort as part of the clinical program of the MetAGE Cluster of Excellence (Austrian Science Fund # 10.55776/COE14) will focus on understanding the metabolic dysregulation associated with aging in a metabolic at-risk population. Metabolic control, which encompasses various aspects and is influenced by numerous aging indicators, might be the primary driver of age-related diseases. For instance, contemporary markers of biological age, such as epigenetic clocks based on DNA methylation and cellular senescence markers, correlate more closely with metabolic processes like nutrient sensing and mitochondrial function rather than genome stability or telomere length.
Aging entails a gradual deterioration of several fundamental metabolic processes, including lipostasis (fat metabolism), proteostasis (protein homeostasis), polyamine metabolism, and mitochondrial function. These intracellular changes are compounded by alterations in intercellular and interorgan communication, affecting brain-organ interactions and immune function. The decline in these crucial processes can disrupt the regulatory mechanisms of metabolic control in a manner influenced by sex and gender. Consequently, the loss of metabolic control may exacerbate other aging processes, setting off a detrimental cycle of accelerated aging.
Disruption in metabolic regulation caused by calorie-rich diets, disturbed circadian rhythms, or sedentary lifestyle can lead to a diverse set of health issues known collectively as metabolic syndrome. These medical conditions, including obesity, high blood pressure, elevated lipid levels, insulin resistance, and high blood sugar, contribute to the development of prevalent age-related diseases such as cardiovascular disease, type 2 diabetes, retinal degeneration and metabolic dysfunction-associated steatotic liver disease, formerly known as nonalcoholic fatty liver disease, affecting millions of older individuals globally. Additionally, there exists a significant link between metabolic imbalance and dysfunction in the immune system, resulting in heightened susceptibility to infections, diminished response to vaccinations, and various neuropsychiatric disorders, especially depression. Hence, understanding the mechanisms underlying metabolic dysregulation holds immense importance in devising preventive measures against some of the most debilitating age-related ailments.
The proposed research project aims to prospectively identify and validate aging biomarkers in relation to age- and sex-related cardiometabolic changes in young and old individuals, who are lean or obese/overweight (i.e. a metabolic at-risk population) with regard to lipostasis, proteostasis, polyamine metabolism, mitochondrial function, inflammation and cellular senescence. The goal is to gain insights into the interaction of obesity related metabolic alteration and aging, and the relevance of loss of metabolic control in the development of age-related diseases in order to build a foundation for targeted drug- and lifestyle interventions in future studies.
- Conditions
- Obesity, Aging, Aging Problems, Metabolic Syndrome
- Being tested
- comprehensive metabolic phenotyping
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive metabolic phenotypingDiagnostic test
The investigators will employ state of the art techniques to metabolically phenotype the study groups using brain, cardiac and whole body magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), wearables, optical coherence tomography longitudinally. In addition, a battery of patient reported outcome measures will be used to explore psychosocial aspects of aging.
| Study group | Role | What they receive |
|---|---|---|
| Lean, young adults | Not described Receives: Diagnostic Test: comprehensive metabolic phenotyping | |
| Overweight, young adults | Not described Receives: Diagnostic Test: comprehensive metabolic phenotyping | |
| Lean, older adults | Not described Receives: Diagnostic Test: comprehensive metabolic phenotyping | |
| Overweight, older adults | Not described Receives: Diagnostic Test: comprehensive metabolic phenotyping | |
| Nonagenerians Age ≥ 90 | Note: Nonagenarian Group will only be phenotyped once Receives: Diagnostic Test: comprehensive metabolic phenotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological age: Epigenetic and clinical clocks
Epigenetic and clinical clocks (i.e. LinAge2, PheoAge) will be measured assessing DNA methylation in whole blood and standard laboratory parameters. The investigators speculate that the biological age is accelerated in obesity/overweight persons independent of chronological age.
Measured: every 3 years
Secondary outcomes (2)
Magnetic resonance spectroscopy
Hepatic lipid content
Measured: every 3 years
Magnetic resonance imaging
Whole body fat distribution
Measured: every 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start5 May 2025
- Primary completion1 Jan 2035 (estimated)
- Study completion1 Jan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Scherer
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz, University of Graz
- Responsible party
- Sponsor-investigator, Thomas Scherer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511297
- Sponsor's protocol ID
- 1632/2024
- Acronym
- Pro-Metage
- Status last verified
- Aug 2025
- First submitted
- 9 Jul 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Control of Aging and Disease - the MetAGE Deep Phenotyping Cohort (Pro-Metage)
- ClinicalTrials.gov ID
- NCT06511297
- Acronym / sponsor ID
- Pro-Metage / 1632/2024
- Conditions
- Obesity, Aging, Aging Problems, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Thomas SchererUniversity, hospital or other
- Collaborators
- Medical University of Graz, University of Graz
- Study start
- 5 May 2025 (actual)
- Primary completion
- 1 Jan 2035 (estimated)
- Study completion
- 1 Jan 2036 (estimated)
- First posted
- 19 Jul 2024 (actual)
- 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.
The goal of this prospective observational study is to identify and validate blood based aging biomarkers in relation to cardiometabolic phenotypes of young and old, female and male subjects with or without obesity.
The main question is to gain insights into the interaction of obesity related metabolic alteration and aging, and the relevance of loss of metabolic control in the development of age-related diseases in order to build a foundation for targeted drug- and lifestyle interventions in future studies.
Detailed description
The ongoing increase in human life expectancy is steadily reshaping the demographic landscape, leading to a higher proportion of older adults, many of whom suffer from multiple health conditions. These unprecedented demographic shifts come at a significant socioeconomic cost, as aging stands as the primary risk factor for chronic disabilities and disorders such as cardiovascular diseases, dementia, type 2 diabetes, obesity, steatotic liver disease and infections. Consequently, promoting healthy aging emerges as one of the most pressing societal challenges in the foreseeable future, underscoring the urgent need for clinically validated strategies to extend the disease-free phase of life, known as health span.
The Pro-MetAGE prospective cohort as part of the clinical program of the MetAGE Cluster of Excellence (Austrian Science Fund # 10.55776/COE14) will focus on understanding the metabolic dysregulation associated with aging in a metabolic at-risk population. Metabolic control, which encompasses various aspects and is influenced by numerous aging indicators, might be the primary driver of age-related diseases. For instance, contemporary markers of biological age, such as epigenetic clocks based on DNA methylation and cellular senescence markers, correlate more closely with metabolic processes like nutrient sensing and mitochondrial function rather than genome stability or telomere length.
Aging entails a gradual deterioration of several fundamental metabolic processes, including lipostasis (fat metabolism), proteostasis (protein homeostasis), polyamine metabolism, and mitochondrial function. These intracellular changes are compounded by alterations in intercellular and interorgan communication, affecting brain-organ interactions and immune function. The decline in these crucial processes can disrupt the regulatory mechanisms of metabolic control in a manner influenced by sex and gender. Consequently, the loss of metabolic control may exacerbate other aging processes, setting off a detrimental cycle of accelerated aging.
Disruption in metabolic regulation caused by calorie-rich diets, disturbed circadian rhythms, or sedentary lifestyle can lead to a diverse set of health issues known collectively as metabolic syndrome. These medical conditions, including obesity, high blood pressure, elevated lipid levels, insulin resistance, and high blood sugar, contribute to the development of prevalent age-related diseases such as cardiovascular disease, type 2 diabetes, retinal degeneration and metabolic dysfunction-associated steatotic liver disease, formerly known as nonalcoholic fatty liver disease, affecting millions of older individuals globally. Additionally, there exists a significant link between metabolic imbalance and dysfunction in the immune system, resulting in heightened susceptibility to infections, diminished response to vaccinations, and various neuropsychiatric disorders, especially depression. Hence, understanding the mechanisms underlying metabolic dysregulation holds immense importance in devising preventive measures against some of the most debilitating age-related ailments.
The proposed research project aims to prospectively identify and validate aging biomarkers in relation to age- and sex-related cardiometabolic changes in young and old individuals, who are lean or obese/overweight (i.e. a metabolic at-risk population) with regard to lipostasis, proteostasis, polyamine metabolism, mitochondrial function, inflammation and cellular senescence. The goal is to gain insights into the interaction of obesity related metabolic alteration and aging, and the relevance of loss of metabolic control in the development of age-related diseases in order to build a foundation for targeted drug- and lifestyle interventions in future studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lean, young adults | – | Diagnostic Test: comprehensive metabolic phenotyping |
| Overweight, young adults | – | Diagnostic Test: comprehensive metabolic phenotyping |
| Lean, older adults | – | Diagnostic Test: comprehensive metabolic phenotyping |
| Overweight, older adults | – | Diagnostic Test: comprehensive metabolic phenotyping |
| Nonagenerians Age ≥ 90 | – | Diagnostic Test: comprehensive metabolic phenotypingNote: Nonagenarian Group will only be phenotyped once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample from eastern Austria.
Key inclusion criteria (17 listed)
- Group 1 - Lean, young adults (n = 150)
- Age 18 - 35 years
- Body mass index (BMI) ≥ 18.5 and ≤ 24.9 kg/m2 (≥ 12 months)
- Group 2 - Overweight, young adults (n = 150)
- Age 18 - 35 years
Key exclusion criteria (43 listed)
- Group 1 - Lean, young adults (n = 150)
- Highly physical active (i.e. > 5 times sporting activity / week with moderate to high intensity [heart rate 140 - 200bpm])
- Special diets (i.e. ketogenic diet and time-restricted eating)
- Clinically significant metabolic or endocrine disorders
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive metabolic phenotypingThe investigators will employ state of the art techniques to metabolically phenotype the study groups using brain, cardiac and whole body magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), wearables, optical coherence tomography longitudinally. In addition, a battery of patient reported outcome measures will be used to explore psychosocial aspects of aging. | Diagnostic test | Lean, older adults, Lean, young adults, Nonagenerians Age ≥ 90, Overweight, older adults, Overweight, young adults |
Primary outcome
Biological age: Epigenetic and clinical clocks
Time frame: every 3 years
Epigenetic and clinical clocks (i.e. LinAge2, PheoAge) will be measured assessing DNA methylation in whole blood and standard laboratory parameters. The investigators speculate that the biological age is accelerated in obesity/overweight persons independent of chronological age.
2 secondary outcomes
Magnetic resonance spectroscopy
Time frame: every 3 years
Magnetic resonance imaging
Time frame: every 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Aging, run by Thomas Scherer at 2 sites in Austria.
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 43 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological age: Epigenetic and clinical clocks (time frame: every 3 years). 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 17 Feb 2026.