Natural Course of Initially Metabolic Healthy Obese Individuals (Healthy Obesity)?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Healthy Obesity, Metabolically. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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?
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.
Primary outcome measures
- 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.]
Secondary outcome measures (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.]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Switzerland · 1 center
- dTIP / ETH Zürich — Baden
Identifiers
NCT: NCT06799897 · 2020-03031