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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-18

Study Completion Date

2026-01-18

Brief Summary

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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?

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Detailed Description

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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.

Conditions

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Healthy Obesity, Metabolically

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes