Obesity, AbdominalNCT06907212
Transcriptional Changes in Isolated Human Adipocytes During Obesity
An observational study of Obesity, Abdominal and Adiposity, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Adipocytes play an important role in our body through their function as metabolic energy stores in the form of fat deposits, which are stored when metabolic energy is in excess and released when energy levels are low. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal, Adiposity
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2023to 1 Sep 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment of subjects will be from patients referred for surgical cholecystectomies, herniotomies or similar operations, at Bispebjerg Hospital.
Who may be able to join
- Age > 18 years old
- BMI> 19 kg/m2
- Can receive oral and written information and give appropriate consent
Who cannot join
- Active viral hepatitis, HIV positive
- Autoimmune diseases (i.e. lupus)
- Chronic use of corticosteroids (cortisone)
- Unable to give appropriate consent
- Contraindications for biopsy: bleeding tendency.
- Cancer or other comorbidity with an expected survival time of less than 12 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Human Adipocytes - Transcriptional Network Changes Associated With Obesity
Adipocytes play an important role in our body through their function as metabolic energy stores in the form of fat deposits, which are stored when metabolic energy is in excess and released when energy levels are low. In severe obesity, adipose tissue grows through the production of more adipocytes from stem cells (hyperplasia) and the increase in the size of existing adipocytes (hypertrophy). This ability of adipocytes, to maintain their functionality during tissue expansion, is critical in determining the development of obesity-related comorbidities. However, not all adipocytes are the same as adipocyte function differs greatly depending on the depot in which they are found. To elucidate the mechanisms underlying adipocyte adaptability, it is necessary to obtain a deep systems biology understanding of how signaling in different types of adipocytes regulates metabolism and function. Currently, this research group is conducting a systems biology analysis of adipocyte plasticity in obesity in mouse models, but adipose tissue biopsies from different depots in humans are lacking and needed to investigate the regulation of adipocyte function and plasticity in humans. Such studies of adipocytes are crucial for the understanding how obesity affects adipose tissue function and leads to comorbidities.
Read the detailed description
The development of overweight and obesity is associated with major changes in adipose tissue, including structural changes in cell type composition as well as gene expression in individual adipose tissue cell types. The molecular mechanisms underlying these changes are not yet known. The investigators therefore hypothesized that overweight and obesity cause changes in the transcriptional program of adipocytes and this leads to impaired function of adipocytes. This study will use advanced genomic technologies available that can measure the dynamic changes in the transcriptome and genomic landscape of isolated adipocytes from patient biopsies, to better understand which changes in the adipocytes in particular underlie the severe comorbidities that occur with the development of obesity. It is expected that the described project will contribute important knowledge about adipocyte-specific transcriptional programs that play a crucial role in obesity. This and thus may contribute to the knowledge required to develop adapted- and personalized medicines, or new therapeutic approaches to treat obesity and its associated diseases.
Recruitment of 100 subjects will be from patients referred for surgical cholecystectomies, herniotomies or similar operations at Bispebjerg Hospital. The control group will consist of study participants with a BMI ≥ 19 kg/m2 and < 25 kg/m2, and the "case" group will consist of study participants with a BMI ≥ 25 kg/m2. When including subjects, emphasis will be placed on achieving a control group of approximately 25 subjects and a "case" group of approximately 75 subjects with varying degrees of elevated BMI.
- Conditions
- Obesity, Abdominal, Adiposity
- Keywords
- Human primary adipocytes, Obesity, Systems-wide biology, Gene regulatory networks
- Medical subject headings
- Obesity, Abdominal, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Male and female participants with various BMI | Both male and female participants will be included, with the goal of creating a cohort in which all levels of BMI are equally present. Adipocytes of the abdominal subcutaneous and visceral adipose tissue depots will be isolated and sequenced to perform linear regression analysis of transcriptional networks across BMI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipocytes specific signaling
RNA sequencing of isolated adipocytes
Measured: June 2024 - Sept 2025
Gene regulatory networks
ATAC sequencing of isolated adipocytes to determine the accessible chromatin regions.
Measured: June 2024 - Sept 2025
Secondary outcomes (3)
Adipocyte cell size
Determining the average adipocyte cell size and cell size distribution in both tissue depots.
Measured: Sept 2024 - Dec 2024
Standard blood tests
Analysis of standard blood tests by research diagnostics department of the hospital; including nutritional status (haemoglobin, magnesium, zinc, phosphate, ferritin, iron, albumin. Vitamin D, urea), coagulation (INR, APTT, platelets), blood lipids (total cholesterol, LDL, HDL, triglycerides) and insulin resistance (HOMA-IR, HbA1c, C-peptide, glucose).
Measured: Jan 2025 - Sept 2025
Adipokine secretion
Storage of extra serum and plasma for additional analysis of adipokines such as Adiponectin and Leptin.
Measured: Jan 2025 - Sept 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Apr 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Sponsor
- Investigators
- Susanne Mandrup, PhD, Principal investigator, s.mandrup@bmb.sdu.dk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907212
- Sponsor's protocol ID
- S-20200123
- Status last verified
- Mar 2025
- First submitted
- 16 Dec 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Adipocytes - Transcriptional Network Changes Associated With Obesity
- ClinicalTrials.gov ID
- NCT06907212
- Acronym / sponsor ID
- S-20200123
- Conditions
- Obesity, Abdominal, Adiposity
- Keywords
- Human primary adipocytes, Obesity, Systems-wide biology, Gene regulatory networks
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 2 Apr 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.
Adipocytes play an important role in our body through their function as metabolic energy stores in the form of fat deposits, which are stored when metabolic energy is in excess and released when energy levels are low. In severe obesity, adipose tissue grows through the production of more adipocytes from stem cells (hyperplasia) and the increase in the size of existing adipocytes (hypertrophy). This ability of adipocytes, to maintain their functionality during tissue expansion, is critical in determining the development of obesity-related comorbidities. However, not all adipocytes are the same as adipocyte function differs greatly depending on the depot in which they are found. To elucidate the mechanisms underlying adipocyte adaptability, it is necessary to obtain a deep systems biology understanding of how signaling in different types of adipocytes regulates metabolism and function. Currently, this research group is conducting a systems biology analysis of adipocyte plasticity in obesity in mouse models, but adipose tissue biopsies from different depots in humans are lacking and needed to investigate the regulation of adipocyte function and plasticity in humans. Such studies of adipocytes are crucial for the understanding how obesity affects adipose tissue function and leads to comorbidities.
Detailed description
The development of overweight and obesity is associated with major changes in adipose tissue, including structural changes in cell type composition as well as gene expression in individual adipose tissue cell types. The molecular mechanisms underlying these changes are not yet known. The investigators therefore hypothesized that overweight and obesity cause changes in the transcriptional program of adipocytes and this leads to impaired function of adipocytes. This study will use advanced genomic technologies available that can measure the dynamic changes in the transcriptome and genomic landscape of isolated adipocytes from patient biopsies, to better understand which changes in the adipocytes in particular underlie the severe comorbidities that occur with the development of obesity. It is expected that the described project will contribute important knowledge about adipocyte-specific transcriptional programs that play a crucial role in obesity. This and thus may contribute to the knowledge required to develop adapted- and personalized medicines, or new therapeutic approaches to treat obesity and its associated diseases.
Recruitment of 100 subjects will be from patients referred for surgical cholecystectomies, herniotomies or similar operations at Bispebjerg Hospital. The control group will consist of study participants with a BMI ≥ 19 kg/m2 and < 25 kg/m2, and the "case" group will consist of study participants with a BMI ≥ 25 kg/m2. When including subjects, emphasis will be placed on achieving a control group of approximately 25 subjects and a "case" group of approximately 75 subjects with varying degrees of elevated BMI.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male and female participants with various BMI | – | –Both male and female participants will be included, with the goal of creating a cohort in which all levels of BMI are equally present. Adipocytes of the abdominal subcutaneous and visceral adipose tissue depots will be isolated and sequenced to perform linear regression analysis of transcriptional networks across BMI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment of subjects will be from patients referred for surgical cholecystectomies, herniotomies or similar operations, at Bispebjerg Hospital.
Key inclusion criteria (3 listed)
- Age > 18 years old
- BMI> 19 kg/m2
- Can receive oral and written information and give appropriate consent
Key exclusion criteria (6 listed)
- Active viral hepatitis, HIV positive
- Autoimmune diseases (i.e. lupus)
- Chronic use of corticosteroids (cortisone)
- Unable to give appropriate consent
- Contraindications for biopsy: bleeding tendency.
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
Adipocytes specific signaling
Time frame: June 2024 - Sept 2025
RNA sequencing of isolated adipocytes
Gene regulatory networks
Time frame: June 2024 - Sept 2025
ATAC sequencing of isolated adipocytes to determine the accessible chromatin regions.
3 secondary outcomes
Adipocyte cell size
Time frame: Sept 2024 - Dec 2024
Standard blood tests
Time frame: Jan 2025 - Sept 2025
Adipokine secretion
Time frame: Jan 2025 - Sept 2025
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 2 Apr 2025.
- Website of main investigating partyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Susanne Mandrup, PhD principal investigator
s.mandrup@bmb.sdu.dk
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 Obesity, Abdominal and Adiposity, run by University of Southern Denmark at 1 site in Denmark.
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 3 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 2 Apr 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 Denmark. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adipocytes specific signaling (time frame: June 2024 - Sept 2025). The study lists 2 primary outcomes in all. 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 2 Apr 2025.