Hernia SurgeryCB1RNCT03202706
Use of Biopsies of Abdominal Subcutaneous Fat to Study the Role of the Activation of Endocannabinoid 1 Receptors (CB1R) on Adipocyte Glucolipid Metabolism
An observational study of Hernia Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Obesity is associated with hyperactivation of the endocannabinoid system, and its inhibition by the administration of CB1 receptor (CB1R) antagonists, leads to a decrease in food intake, weight loss and an improvement in metabolic parameters. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Hernia Surgery
- What is being tested?
- Samples of adipose tissue
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2016to 7 Jan 2020
- Phase
- Observational
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing surgery for hernia
Who may be able to join
- men aged 18 to 70 years
- persons who have provided oral consent
- persons undergoing surgery for hernia
- men aged 18 to 70 years
- BMI > 30
- persons who have provided oral consent
Show all 12Show fewer
- persons undergoing surgery for hernia
- men aged 18 to 70 years
- type 2 diabetic not treated with Insulin or GLP-1 agonist
- BMI > 30
- persons who have provided oral consent
- persons undergoing surgery for hernia
Who cannot join
- persons without health insurance cover
- BMI > 30
- diabetes
- associated diseases: cancer, chronic inflammatory diseases
- adults under guardianship
- obese subjects
Show all 14Show fewer
- persons without health insurance cover
- diabetes
- associated diseases: cancer, chronic inflammatory diseases
- adults under guardianship
- diabetic obese subjects
- persons without health insurance cover
- associated diseases: cancer, chronic inflammatory diseases
- adults under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Obesity is associated with hyperactivation of the endocannabinoid system, and its inhibition by the administration of CB1 receptor (CB1R) antagonists, leads to a decrease in food intake, weight loss and an improvement in metabolic parameters. Even though the reduction in food intake following central CB1R inactivation seems to be the principal cause of weight loss and the improvement in metabolic parameters, several studies in animals and humans have indicated that peripheral CB1R could also be implicated in the regulation of glucolipid metabolism. As a result, it has been suggested that the long-term beneficial effects of inactivation of the endocannabinoid system are due to both central effects on food intake and peripheral effects involving adipose tissue, the liver, skeletal muscle and the pancreas. It appears essential to determine the role of CB1R located in peripheral tissues and in particular in adipose tissue, which plays an active role in maintaining glucolipid homeostasis. The experiments conducted in this project consist in studying in biopsies of abdominal subcutaneous fat whether activation of adipocyte CB1R modifies adipocyte metabolism by determining the mechanisms. The investigators hypothesize that activation of CB1R in adipose tissue will lead to the stimulation of lipolysis dependent on the alteration of the insulin signal, and therefore that inactivation of the endocannabinoid system by blocking peripheral CB1R could constitute a therapeutic approach to improve obesity-related insulin resistance and dyslipidaemia.
- Conditions
- Hernia Surgery
- Being tested
- Samples of adipose tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samples of adipose tissueProcedure or surgery
Samples of visceral and subcutaneous adipose tissue collected during hernia surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Procedure: Samples of adipose tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucolipid metabolism analysis in human abdominal subcutaneous and visceral fat
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start24 Feb 2016
- Primary completion7 Jan 2020
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202706
- Sponsor's protocol ID
- VERGES 2015
- Acronym
- CB1R
- Status last verified
- Feb 2024
- First submitted
- 21 Jun 2017
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Biopsies of Abdominal Subcutaneous Fat to Study the Role of the Activation of Endocannabinoid 1 Receptors (CB1R) on Adipocyte Glucolipid Metabolism
- ClinicalTrials.gov ID
- NCT03202706
- Acronym / sponsor ID
- CB1R / VERGES 2015
- Conditions
- Hernia Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 24 Feb 2016 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 28 Jun 2017 (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 is associated with hyperactivation of the endocannabinoid system, and its inhibition by the administration of CB1 receptor (CB1R) antagonists, leads to a decrease in food intake, weight loss and an improvement in metabolic parameters. Even though the reduction in food intake following central CB1R inactivation seems to be the principal cause of weight loss and the improvement in metabolic parameters, several studies in animals and humans have indicated that peripheral CB1R could also be implicated in the regulation of glucolipid metabolism. As a result, it has been suggested that the long-term beneficial effects of inactivation of the endocannabinoid system are due to both central effects on food intake and peripheral effects involving adipose tissue, the liver, skeletal muscle and the pancreas. It appears essential to determine the role of CB1R located in peripheral tissues and in particular in adipose tissue, which plays an active role in maintaining glucolipid homeostasis. The experiments conducted in this project consist in studying in biopsies of abdominal subcutaneous fat whether activation of adipocyte CB1R modifies adipocyte metabolism by determining the mechanisms. The investigators hypothesize that activation of CB1R in adipose tissue will lead to the stimulation of lipolysis dependent on the alteration of the insulin signal, and therefore that inactivation of the endocannabinoid system by blocking peripheral CB1R could constitute a therapeutic approach to improve obesity-related insulin resistance and dyslipidaemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Samples of adipose tissue |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing surgery for hernia
Key inclusion criteria (12 listed)
- men aged 18 to 70 years
- persons who have provided oral consent
- persons undergoing surgery for hernia
- men aged 18 to 70 years
- BMI > 30
Key exclusion criteria (14 listed)
- persons without health insurance cover
- BMI > 30
- diabetes
- associated diseases: cancer, chronic inflammatory diseases
- adults under guardianship
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 |
|---|---|---|
| Samples of adipose tissueSamples of visceral and subcutaneous adipose tissue collected during hernia surgery | Procedure or surgery | Patients |
Primary outcome
Glucolipid metabolism analysis in human abdominal subcutaneous and visceral fat
Time frame: Baseline
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 22 Feb 2024.
Related trials for Hernia Surgery
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruiting
Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Recruiting
Desarda Tissue Technique vs Lichtenstein Technique for Primary Inguinal Hernia Repair
Inguinal Hernia Unilateral, Complications of Surgical Procedures or Medical Care
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
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?
An observational study of Hernia Surgery, run by Centre Hospitalier Universitaire Dijon 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 12 inclusion and 14 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 22 Feb 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?
Glucolipid metabolism analysis in human abdominal subcutaneous and visceral fat (time frame: Baseline). 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 22 Feb 2024.