NCT06511297

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
118mo left

Started May 2025

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
May 2025Jan 2036

First Submitted

Initial submission to the registry

July 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

May 5, 2025

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2035

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2036

Last Updated

February 17, 2026

Status Verified

August 1, 2025

Enrollment Period

9.7 years

First QC Date

July 9, 2024

Last Update Submit

February 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    every 3 years

Secondary Outcomes (2)

  • Magnetic resonance spectroscopy

    every 3 years

  • Magnetic resonance imaging

    every 3 years

Other Outcomes (5)

  • Vibration-controlled transient elastography

    every 3 years

  • Body composition

    every 3 years

  • Continuous glucose monitoring

    every 3 years

  • +2 more other outcomes

Study Arms (5)

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

Note: Nonagenarian Group will only be phenotyped once

Diagnostic Test: comprehensive metabolic phenotyping

Interventions

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.

Lean, older adultsLean, young adultsNonagenerians Age ≥ 90Overweight, older adultsOverweight, young adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample from eastern Austria.

You may qualify if:

  • 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)
  • +2 more criteria

You may not qualify if:

  • 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
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of Graz

Graz, Styria, Austria

RECRUITING

Medical University of Vienna

Vienna, Vienna, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, hair, saliva, mucosa cells, stool, urine

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof. Dr. med.

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 19, 2024

Study Start

May 5, 2025

Primary Completion (Estimated)

January 1, 2035

Study Completion (Estimated)

January 1, 2036

Last Updated

February 17, 2026

Record last verified: 2025-08

Locations