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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06799897
Enrollment
300
Registered
2025-01-29
Start date
2023-01-18
Completion date
2026-01-18
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Obesity, Metabolically

Keywords

Obesity, Healthy

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.

Interventions

None listed

Sponsors

ETH Zurich
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Rate of conversionConversion will be driven by the occurrence of pathological findings caused by obesity (metabolic or cardiovascular pathologies). Through study completion, an average of 1 year.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.

Secondary

MeasureTime frameDescription
Rate of identification of factorsConversion will be driven by the occurrence of pathological findings caused by obesity (metabolic or cardiovascular pathologies), through study completion, an average of 1 year.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...

Countries

Switzerland

Contacts

Primary ContactJörg Goldhahn, Prof.
jgoldhahn@ethz.ch044 633 70 54
Backup ContactSusanne Müller, MSc
susanne.mueller@dtip.ethz.ch044 633 70 54

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026