Metabolic Control of Aging and Disease - the MetAGE Deep Phenotyping Cohort
Recruiting · NCT06511297 · Observational (researchers observe without assigning treatment) · Lead sponsor: Thomas Scherer
View the official record on ClinicalTrials.gov →Interventions studied
comprehensive metabolic phenotyping
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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)
- 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)
Exclusion criteria
- 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
- 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.
Where it is running
2 locations listed.
- Medical University of Vienna - Vienna, State of Vienna, Austria
- Medical University of Graz - Graz, Styria, Austria