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?

Study Overview

• Status: Recruiting
• Conditions: Healthy Obesity, Metabolically

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Jörg Goldhahn, Prof.; Phone Number: 044 633 70 54; Email: jgoldhahn@ethz.ch
• Study Contact Backup: Name: Susanne Müller, MSc; Phone Number: 044 633 70 54; Email: susanne.mueller@dtip.ethz.ch

Study Locations

• Switzerland
  • Baden, Switzerland, 5404
    • Recruiting
    • dTIP / ETH Zürich
    • Contact: Susanne Müller; Email: susanne.mueller@dtip.ethz.ch
    • Contact: Sonia Strangio; Email: sonia.strangio@dtip.ethz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

obese participants

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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...	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.

Collaborators and Investigators

• Sponsor: ETH Zurich
• Investigators: Study Chair: Jörg Goldhahn, Prof., dTIP / ETH Zürich

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Estimated): January 18, 2026
• Study Completion (Estimated): January 18, 2026

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Healthy
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity, Metabolically Benign; Obesity
• Other Study ID Numbers: 2020-03031

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No