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RecruitingNCT06799897Updated May 30, 2025

Natural Course of Initially Metabolic Healthy Obese Individuals (Healthy Obesity)?

An observational study in Healthy Obesity, Metabolically, sponsored by ETH Zurich. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by ETH Zurich · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The main goal of this study is to gain a thorough understanding, which specific factors drive the unhealthy sequelae of obesity. Therefore, the investigators want to understand:

  1. What distinguishes obese persons without metabolic diseases from those with medical diseases in a cross-sectional comparison?
  2. Which factors drive the conversions from metabolically healthy obesity into a metabolically unhealthy obesity in a longitudinal approach?
Read the detailed description

The hypothesis is, that changes in the molecular regulation of adipose tissue as well as in adipose tissue cellular composition are responsible for the development of a rather metabolic healthy or unhealthy phenotype. Knowledge of these factors will be used to generate new diagnostic concepts for personalized risk prediction and will furthermore serve as the basis to develop novel strategies to target adipose tissue to improve metabolic health.

02

Conditions studied

  • Healthy Obesity, Metabolically

Keywords

  • Obesity
  • Healthy
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

obese participants

Eligibility criteria

Inclusion Criteria:

  • Signed Informed Consent Form
  • Age between 18 and 60 years
  • BMI 30-50 kg/m2
  • Knowledge of German, which requires sufficient written and allow oral patient education

Inclusion criteria for initially healthy group

  • Blood pressure \< 140/90 mmHg
  • Normal glucose metabolism

    • HbA1c \< 6.5 %
    • Fasting Glucose \< 7.0 mmol/l
  • Normal lipid metabolism

    o LDL-cholesterol \< 5.0 mmol/l

  • ≤ 2 of the following metabolic syndrome criteria combined (excluding waist circumference)
  • TG > 1.7 mmol/l
  • HDL-cholesterol > 1.0 mmol/l (male) / > 1.3 mmol/l (female)
  • Fasting glucose ≥ 5.6 mmol/l
  • BP ≥ 130/85 mmHg

Exclusion Criteria:

  • Pregnancy
  • Medication and / or pathologies that prevent a safe execution of the fat tissue biopsies
  • History of or planned bariatric operation
  • Medical conditions that prevent examinations and testing (e.g. symptomatic cardiovascular diseases)
  • Active Malignant tumor (\<2a remission)
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Rate of conversion

    The primary endpoint is the conversion (through study completions, 10 years) from obese but metabolically healthy subjects into obese patients in a pathological metabolic state, through study completion an average of 1 year.

    Time frame: Conversion will be driven by the occurrence of pathological findings caused by obesity (metabolic or cardiovascular pathologies). Through study completion, an average of 1 year.

Secondary outcomes

  1. Rate of identification of factors

    The secondary endpoint is the identification of factors alone or in combination (through study completions, 10 years), that related to this conversion from healthy into pathological obesity. This includes factors like: DEXA scans, White Adipose Tissue, lipid and glucose metabolism, vital signs, physical activity, general health and quality of life status...

    Time frame: Conversion will be driven by the occurrence of pathological findings caused by obesity (metabolic or cardiovascular pathologies), through study completion, an average of 1 year.

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT06799897
Lead sponsor
ETH Zurich
Responsible party
Sponsor
First posted
Jan 29, 2025
Start date
Jan 18, 2023
Primary completion
Jan 18, 2026 (estimated)
Completion
Jan 18, 2026 (estimated)
Last update
May 30, 2025

Study contacts

Jörg Goldhahn, Prof.
Contact
jgoldhahn@ethz.ch
044 633 70 54
Susanne Müller, MSc
Contact
susanne.mueller@dtip.ethz.ch
044 633 70 54
Jörg Goldhahn, Prof.
study chair · dTIP / ETH Zürich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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