Healthy Obesity, MetabolicallyNCT06799897
Natural Course of Initially Metabolic Healthy Obese Individuals (Healthy Obesity)?
An observational study of Healthy Obesity, Metabolically, run by ETH Zurich at 1 site in Switzerland.
Trial 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. What distinguishes obese persons without metabolic diseases from those with medical diseases in a cross-sectional comparison? 2. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Obesity, Metabolically
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Jan 2023to 18 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: obese participants
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
dTIP / ETH Zürich
Baden, 5404
Susanne Müller, susanne.mueller@dtip.ethz.ch
Sonia Strangio, sonia.strangio@dtip.ethz.ch
About this study
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:
- What distinguishes obese persons without metabolic diseases from those with medical diseases in a cross-sectional comparison?
- Which factors drive the conversions from metabolically healthy obesity into a metabolically unhealthy obesity in a longitudinal approach?
Read the 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.
- Conditions
- Healthy Obesity, Metabolically
- Keywords
- Obesity, Healthy
- Medical subject headings
- Obesity, Metabolically Benign, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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...
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start18 Jan 2023
- Primary completion18 Jan 2026 (estimated)
- Study completion18 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Obesity, MetabolicallyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ETH Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörg Goldhahn, Prof., Study chair, dTIP / ETH Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799897
- Sponsor's protocol ID
- 2020-03031
- Status last verified
- May 2025
- First submitted
- 18 Jul 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Course of Initially Metabolic Healthy Obese Individuals (Healthy Obesity)?
- ClinicalTrials.gov ID
- NCT06799897
- Acronym / sponsor ID
- 2020-03031
- Conditions
- Healthy Obesity, Metabolically
- Keywords
- Obesity, Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- ETH ZurichUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 18 Jan 2026 (estimated)
- Study completion
- 18 Jan 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What distinguishes obese persons without metabolic diseases from those with medical diseases in a cross-sectional comparison?
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- obese participants
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jörg Goldhahn, Prof. study chair
dTIP / ETH Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Obesity, Metabolically, run by ETH Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jörg Goldhahn, Prof. (044 633 70 54, jgoldhahn@ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.