Clinical trial NCT06799897: Natural Course of Initially Metabolic Healthy Obese Individuals (Healthy Obesity)?
Official title: Natural Course of Initially Metabolic Healthy Obese Individuals (Healthy Obesity)?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Obesity, Metabolically
Keywords: Obesity
Healthy
Lead sponsor: ETH Zurich
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obese participants

Brief 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?

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.

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)

Primary outcomes:
measure: Rate of conversion
timeFrame: 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:
measure: Rate of identification of factors
timeFrame: 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.
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: dTIP / ETH Zürich
Study officials:
affiliation: dTIP / ETH Zürich
name: Jörg Goldhahn, Prof.
role: STUDY_CHAIR
References: