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

ETH Zurich300 enrolled

Overview

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?

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

300

Conditions

Healthy Obesity, Metabolically

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

dTIP / ETH Zürich

Baden, Switzerland

RECRUITING

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

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...

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.

Central 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

Data from ClinicalTrials.gov

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