ObesityOBADEXNCT05843747
Ex Vivo Transformation of White Adipose Tissue (WAT) Into Brown Adipose Tissue (BAT) in Morbidly Obese Patients Using the Ex Vivo Adipocyte Expansion (ExAdEx) Approach: Proof of Concept. From White to Brown Adipose Tissue
A study testing Sampling in people with Obesity, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Obesity and metabolic associated diseases such as type 2 diabetes, NASH, cardiovascular diseases, are the dysregulation of energy homeostasis associated with an imbalance between different types of adipose tissues (ATs). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2023to 18 Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Karnofsky index > 70
- IMC > 35 kg/m2 associated with a comorbidity : hypertension ; type 2 diabetes; disabling osteoarthritis; sleep apnea syndrome with device.
- Failure of a previous well-conducted medical treatment (multidisciplinary management of more than six months preoperatively)
Who cannot join
- Psychiatric counter-indications
- Anaesthetic counter-indications
- Progressive neoplastic pathologies
- Chronic alcoholism
- Severe uncontrolled infection
- Renal failure (Cockroft's clearance <30ml/min)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Obesity and metabolic associated diseases such as type 2 diabetes, NASH, cardiovascular diseases, are the dysregulation of energy homeostasis associated with an imbalance between different types of adipose tissues (ATs). White AT (WAT) which stores energy and functions as a fat storage depot, is fibrotic whith chronic inflammation and is found in excess. On the other hand, brown and beige ATs (BATs), considered as the good ATs because they regulate energy expenditure, are almost undetectable in individuals with obesity. In addition, BAT and WAT produce different hormones that are involved in the control of energy homeostasis via central and peripheral actions. A promising emerging therapeutic approach is to restore BAT in patients with severe obesity in two ways, i) by stimulating BAT in individuals with obesity by pharmacological treatment, ii) by injecting BAT into individuals with obesity using a cell-based therapy approach. However, the development of these two proposals is limited both by the lack of in vitro preclinical BAT models relevant for the screening and validation stages of drug candidates, and by the lack of physiologically functional BAT compatible with tissue graft. The bottleneck is the absence of an unlimited source of human BAT.
The ExAdEX technology makes possible in vitro to turn WAT derived from lean donors into BAT. This new technology offers the possibility of having in vitro predictive human 3D models suitable for the identification and characterization of compounds affecting AT biology, and paves the way for the production of BAT for cell-based therapy of obesity and associated metabolic diseases.
The Primary objective of the study is addressed the effectiveness of the ExAdEx process to induce, ex vivo, the conversion of WAT from obese patients into TAB. The secondary objectives are 1) to compare the efficacy for conversion into BAT when WAT derived from either from visceral or from subcutaneous AT; 2) to investigate the capacity of the ExAdEX-BAT to produce the FGF21 and adiponectin batokines and to respond to insulin.
- Conditions
- Obesity
- Being tested
- Sampling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingOther
During thier bariatric surgery, samples of adipose tissue will be done
| Study group | Role | What they receive |
|---|---|---|
| Sampling | Experimental | Not described Receives: Other: Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
WAT/TAB conversion
WAT/BAT conversion efficiency based on the expression level of the UCP1 marker in the cultures
Measured: At 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start13 Nov 2023
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843747
- Sponsor's protocol ID
- 22-AOIP-04
- Acronym
- OBADEX
- Status last verified
- Jan 2024
- First submitted
- 25 Apr 2023
- Last updated
- 31 Jan 2024
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Transformation of White Adipose Tissue (WAT) Into Brown Adipose Tissue (BAT) in Morbidly Obese Patients Using the Ex Vivo Adipocyte Expansion (ExAdEx) Approach: Proof of Concept. From White to Brown Adipose Tissue
- ClinicalTrials.gov ID
- NCT05843747
- Acronym / sponsor ID
- OBADEX / 22-AOIP-04
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 6 May 2023 (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.
Obesity and metabolic associated diseases such as type 2 diabetes, NASH, cardiovascular diseases, are the dysregulation of energy homeostasis associated with an imbalance between different types of adipose tissues (ATs). White AT (WAT) which stores energy and functions as a fat storage depot, is fibrotic whith chronic inflammation and is found in excess. On the other hand, brown and beige ATs (BATs), considered as the good ATs because they regulate energy expenditure, are almost undetectable in individuals with obesity. In addition, BAT and WAT produce different hormones that are involved in the control of energy homeostasis via central and peripheral actions. A promising emerging therapeutic approach is to restore BAT in patients with severe obesity in two ways, i) by stimulating BAT in individuals with obesity by pharmacological treatment, ii) by injecting BAT into individuals with obesity using a cell-based therapy approach. However, the development of these two proposals is limited both by the lack of in vitro preclinical BAT models relevant for the screening and validation stages of drug candidates, and by the lack of physiologically functional BAT compatible with tissue graft. The bottleneck is the absence of an unlimited source of human BAT.
The ExAdEX technology makes possible in vitro to turn WAT derived from lean donors into BAT. This new technology offers the possibility of having in vitro predictive human 3D models suitable for the identification and characterization of compounds affecting AT biology, and paves the way for the production of BAT for cell-based therapy of obesity and associated metabolic diseases.
The Primary objective of the study is addressed the effectiveness of the ExAdEx process to induce, ex vivo, the conversion of WAT from obese patients into TAB. The secondary objectives are 1) to compare the efficacy for conversion into BAT when WAT derived from either from visceral or from subcutaneous AT; 2) to investigate the capacity of the ExAdEX-BAT to produce the FGF21 and adiponectin batokines and to respond to insulin.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sampling | Experimental | Other: Sampling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Karnofsky index > 70
- IMC > 35 kg/m2 associated with a comorbidity : hypertension ; type 2 diabetes; disabling osteoarthritis; sleep apnea syndrome with device.
- Failure of a previous well-conducted medical treatment (multidisciplinary management of more than six months preoperatively)
Key exclusion criteria (7 listed)
- Psychiatric counter-indications
- Anaesthetic counter-indications
- Progressive neoplastic pathologies
- Chronic alcoholism
- Severe uncontrolled infection
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 |
|---|---|---|
| SamplingDuring thier bariatric surgery, samples of adipose tissue will be done | Other | Sampling |
Primary outcome
WAT/TAB conversion
Time frame: At 1 month
WAT/BAT conversion efficiency based on the expression level of the UCP1 marker in the cultures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling in people with Obesity, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 7 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: finished, as of the sponsor's last update on 31 Jan 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
WAT/TAB conversion (time frame: At 1 month). 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 31 Jan 2024.