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NCT Number: NCT06799897

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

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?

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Rate of conversion

    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.

    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 outcomes

  1. Rate of identification of factors

    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.

    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...

Study contacts

Contact information is provided by the study sponsor or research team.

Jörg Goldhahn, Prof.

CONTACT

[email protected]

044 633 70 54

Susanne Müller, MSc

CONTACT

[email protected]

044 633 70 54

Sponsors and collaborators

Lead sponsor

ETH Zurich

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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