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

NCT06799897 | Recruiting

• 1 other identifier: 2020-03031
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Obesity, Metabolically

Keywords

Obesity; Healthy

Outcome Measures

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.

  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

  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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

obese participants

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• ETH Zurich: lead

Study Sites (1)

dTIP / ETH Zürich

Baden, 5404, Switzerland

RECRUITING

MeSH Terms

Conditions

Obesity, Metabolically Benign; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jörg Goldhahn, Prof.

  dTIP / ETH Zürich

  STUDY CHAIR

Central Study Contacts

Jörg Goldhahn, Prof.

CONTACT

044 633 70 54; jgoldhahn@ethz.ch

Susanne Müller, MSc

CONTACT

044 633 70 54; susanne.mueller@dtip.ethz.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: January 29, 2025
• Study Start: January 18, 2023
• Primary Completion: January 18, 2026
• Study Completion: January 18, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

CH (1)