Adipose TissueEOBECMNCT06304506
Effect of Obesity on Extracellular Matrix Composition
A study testing Cross sectional study in people with Adipose Tissue, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The experiment is a simple cross-sectional study with three groups (n=10) in each group, young and old healthy men and obese young men. The study will investigate the composition of the adipose tissue extra cellular matrix. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adipose Tissue
- What is being tested?
- Cross sectional study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men aged [18,35] and BMI [20,25]
- Obese men aged [18,35] and BMI [30,40]
- Healthy older men aged [60,75] and BMI [20,25]
Who cannot join
- Present or former cardiovascular disease and chronical inflammatory disease
- Consumption of medications and supplements that influence substrate use at rest and/or during exercise
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Xlab, Faculty of Health and Medical Sciences, University of Copenhagen
Copenhagen, 2200
Jørn M Helge, PhD, +4528757506, jhelge@sund.ku.dk
About this study
Official title: Effect of Obesity on Extracellular Matrix Composition in Healthy Males With Normal and High BMI
The experiment is a simple cross-sectional study with three groups (n=10) in each group, young and old healthy men and obese young men. The study will investigate the composition of the adipose tissue extra cellular matrix.
The main questions to answer,
- is there differences in the adipose tissue extracellular matrix in obese compared to young men is there differences in the adipose tissue extracellular matrix in old compared to young men
Read the detailed description
Three groups of young (n=10) and old (n=10) healthy men and obese young (n=10) men are recruited.
After verbal and written information is provided signed consent is obtained.
Subjects arrive at the lab overnight fasted and not having done exercise the prior day and having consumed a normal isocaloric carbohydrate rich diet.
After a voiding and a 15 min rest body composition is determined by DXA. After this blood pressure is measured in the supine position in triplicate separated by 1 min. Following this a venous blood sample is obtained from a cubital vein, and kept on ice until further handling.
Subsequently an adipose tissue biopsy is obtained by the Bergström technique applied with suction from an incision 3-5 cm lateral from the umbilicus. After compression and a 30 min rest, the subject perform an incremental exercise test to determine maximal fat oxidation. In brief pulmonary oxygen uptake and carbon dioxide excretion is measured using a COSMED Quark B2 on-line system during 5 min rest sitting on a cycle ergometer, and then during exercise with 3 min increments starting at 60 Watt and increasing by 35 watts. When the respiratory exchange ratio is above 1 the exercise is stopped. After a 5 min break an incremental test until voluntary exhaustion is performed to determine maximal oxygen uptake. This completes the experiment.
- Conditions
- Adipose Tissue
- Being tested
- Cross sectional study
- Keywords
- Extracellular matrix compostion, Obesity, Age
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross sectional studyOther
Physiological testing, Sampling of blood and abdominal adipose tissue and respiratory measurements at rest and during exercise
| Study group | Role | What they receive |
|---|---|---|
| Young obese men | Experimental | BMI [30, 40] Age [18, 35] Receives: Other: Cross sectional study |
| Young healthy men | Experimental | BMI [20, 25] Age [18, 35] Receives: Other: Cross sectional study |
| Old healthy men | Experimental | BMI [20, 25] Age [60, 75] Receives: Other: Cross sectional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of obesity and age on adipose tissue extracellular matrix composition
Adipose tissue extracellular matrix composition will be measured in abdominal subcutaneous adipose tissue sampled 3-5 cm lateral to the umbilicus in 30 male subjects; hereof 10 young, 10 old and 10 young and obese.
In brief the tissue will be delipidated and subsequently separated by DEAE chromotography (A weak anion exchange) and subsequently analysis of glycosaminoglycan disaccharide composition will be performed by MS.
Measured: The human experimental days will be done over the first 6 months of 2024. After informed consent is obtained, each participant will be tested on one day. The laboratory tissue analysis will be performed second half of 2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adipose TissueStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cross sectional study with three groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jørn Wulff Helge, University of Copenhagen
- Investigators
- Jørn W Helge, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304506
- Sponsor's protocol ID
- 514-0894/23-3000
- Acronym
- EOBECM
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When the experiments are concluded and the paper(s) are accepted that data will be able upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Obesity on Extracellular Matrix Composition in Healthy Males With Normal and High BMI
- ClinicalTrials.gov ID
- NCT06304506
- Acronym / sponsor ID
- EOBECM / 514-0894/23-3000
- Conditions
- Adipose Tissue
- Keywords
- Extracellular matrix compostion, Obesity, Age
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 Mar 2024 (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 experiment is a simple cross-sectional study with three groups (n=10) in each group, young and old healthy men and obese young men. The study will investigate the composition of the adipose tissue extra cellular matrix.
The main questions to answer,
- is there differences in the adipose tissue extracellular matrix in obese compared to young men is there differences in the adipose tissue extracellular matrix in old compared to young men
Detailed description
Three groups of young (n=10) and old (n=10) healthy men and obese young (n=10) men are recruited.
After verbal and written information is provided signed consent is obtained.
Subjects arrive at the lab overnight fasted and not having done exercise the prior day and having consumed a normal isocaloric carbohydrate rich diet.
After a voiding and a 15 min rest body composition is determined by DXA. After this blood pressure is measured in the supine position in triplicate separated by 1 min. Following this a venous blood sample is obtained from a cubital vein, and kept on ice until further handling.
Subsequently an adipose tissue biopsy is obtained by the Bergström technique applied with suction from an incision 3-5 cm lateral from the umbilicus. After compression and a 30 min rest, the subject perform an incremental exercise test to determine maximal fat oxidation. In brief pulmonary oxygen uptake and carbon dioxide excretion is measured using a COSMED Quark B2 on-line system during 5 min rest sitting on a cycle ergometer, and then during exercise with 3 min increments starting at 60 Watt and increasing by 35 watts. When the respiratory exchange ratio is above 1 the exercise is stopped. After a 5 min break an incremental test until voluntary exhaustion is performed to determine maximal oxygen uptake. This completes the experiment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cross sectional study with three groups
| Arm | Type | Receives |
|---|---|---|
| Young obese men | Experimental | Other: Cross sectional studyBMI [30, 40] Age [18, 35] |
| Young healthy men | Experimental | Other: Cross sectional studyBMI [20, 25] Age [18, 35] |
| Old healthy men | Experimental | Other: Cross sectional studyBMI [20, 25] Age [60, 75] |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy men aged [18,35] and BMI [20,25]
- Obese men aged [18,35] and BMI [30,40]
- Healthy older men aged [60,75] and BMI [20,25]
Key exclusion criteria (2 listed)
- Present or former cardiovascular disease and chronical inflammatory disease
- Consumption of medications and supplements that influence substrate use at rest and/or during exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross sectional studyPhysiological testing, Sampling of blood and abdominal adipose tissue and respiratory measurements at rest and during exercise | Other | Old healthy men, Young healthy men, Young obese men |
Primary outcome
The effect of obesity and age on adipose tissue extracellular matrix composition
Time frame: The human experimental days will be done over the first 6 months of 2024. After informed consent is obtained, each participant will be tested on one day. The laboratory tissue analysis will be performed second half of 2024.
Adipose tissue extracellular matrix composition will be measured in abdominal subcutaneous adipose tissue sampled 3-5 cm lateral to the umbilicus in 30 male subjects; hereof 10 young, 10 old and 10 young and obese. In brief the tissue will be delipidated and subsequently separated by DEAE chromotography (A weak anion exchange) and subsequently analysis of glycosaminoglycan disaccharide composition will be performed by MS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Yes. When the experiments are concluded and the paper(s) are accepted that data will be able upon reasonable request
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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. This study is not recruiting at the moment.
Jørn W Helge, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross sectional study in people with Adipose Tissue, run by University of Copenhagen 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 2 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jørn Wulff W Helge, PhD (+4528757506, jhelge@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of obesity and age on adipose tissue extracellular matrix composition (time frame: The human experimental days will be done over the first 6 months of 2024. After informed consent is obtained, each participant will be tested on one day. The laboratory tissue analysis will be performed second half of 2024.). 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 12 Mar 2024.