Bariatric Surgery CandidateNCT04984785
Lipid Metabolism in Obese Subjects Undergoing Bariatric Surgery
An observational study of Bariatric Surgery Candidate and Lipid Metabolism Disorders, run by University of Cagliari at 1 site in Italy.
Trial summary
The aim of the study is to evaluate modifications in the metabolism of polyunsaturated fatty acids (PUFA) and biosynthesis of the lipid mediators N-acylethanolamines (NAE), both known to induce and be induced by the nuclear peroxisome proliferator-activated receptor (PPAR)-α, which may also explain the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bariatric Surgery Candidate, Lipid Metabolism Disorders, Obesity
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2019to 7 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients eligible for bariatric surgery
Who may be able to join
- subjects with pathological obesity suitable for bariatric surgery
- Body Mass Index (BMI) range 35-59
Who cannot join
- established diagnoses of a major disease (e.g., diabetes or kidney disease)
- pregnancy or breastfeeding,
- food allergies,
- use of drugs that could affect lipid metabolism
Trial locations and contacts
1 site in 1 country.
Italy1 site
Centro di Chirurgia Bariatrica dell'Azienda Ospedaliera G. Brotzu
Cagliari
About this study
Official title: Characterization of Physiological Mechanisms Involved in the Regulation of Eating Behavior for the Identification of Innovative Nutritional Strategies for Obese Patients Before and After Bariatric Surgery
The aim of the study is to evaluate modifications in the metabolism of polyunsaturated fatty acids (PUFA) and biosynthesis of the lipid mediators N-acylethanolamines (NAE), both known to induce and be induced by the nuclear peroxisome proliferator-activated receptor (PPAR)-α, which may also explain the well-established improved lipid and energy metabolism after bariatric surgery. The study is focused on understanding the weight loss mechanisms in order to develop targeted dietary protocols.
Read the detailed description
The study involves a careful preliminary medical history of the patients, with physical examination, anthropometric parameters measurements and blood sampling for blood chemistry routine and evaluation of any adverse events to assess suitability for the study. The evening before bariatric surgery, one month and six months after bariatric surgery anthropometric parameters measurements, blood sampling for blood chemistry routine, inflammatory and lipid-metabolomic profile, and evaluation of any adverse events are performed. For the study samples are stored identified by a code to be analyzed anonymously. Study interruption criteria are: development of allergic reactions, ketonemia> 1.5 mmol/L, acute gout
- Keywords
- Fatty Acids, Nonesterified, Peroxisome Proliferator-Activated Receptors, Endocannabinoids, N-acylethanolamines
- Medical subject headings
- Lipid Metabolism Disorders, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Modifications of Endocannabinoid and N-acylethanolamine plasma levels
These lipid derivatives are involved in control of energy expenditure and lipid metabolism and are measured by LC MS/MS and expressed as nmol/ml plasma
Measured: 6 months
Weight loss as kg, and fat mass reduction as total kg and percent of body mass
Indicators of the success of the intervention
Measured: 6 months
Changes in fatty acid plasma profile induced by bariatric surgery
Fatty acid profile affect lipid derivatives. Fatty acid are measured by LC and GC and expressed as nmol/ml plasma
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Feb 2019
- Primary completion4 Nov 2019
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Brotzu
- Responsible party
- Principal investigator, Sebastiano Banni, University of Cagliari
- Investigators
- Sebastiano Banni, PhD, Principal investigator, Università di Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984785
- Sponsor's protocol ID
- unica
- Status last verified
- Jul 2021
- First submitted
- 31 May 2021
- Last updated
- 2 Aug 2021
- 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 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Physiological Mechanisms Involved in the Regulation of Eating Behavior for the Identification of Innovative Nutritional Strategies for Obese Patients Before and After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04984785
- Acronym / sponsor ID
- unica
- Keywords
- Fatty Acids, Nonesterified, Peroxisome Proliferator-Activated Receptors, Endocannabinoids, N-acylethanolamines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Brotzu
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 2 Aug 2021 (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 aim of the study is to evaluate modifications in the metabolism of polyunsaturated fatty acids (PUFA) and biosynthesis of the lipid mediators N-acylethanolamines (NAE), both known to induce and be induced by the nuclear peroxisome proliferator-activated receptor (PPAR)-α, which may also explain the well-established improved lipid and energy metabolism after bariatric surgery. The study is focused on understanding the weight loss mechanisms in order to develop targeted dietary protocols.
Detailed description
The study involves a careful preliminary medical history of the patients, with physical examination, anthropometric parameters measurements and blood sampling for blood chemistry routine and evaluation of any adverse events to assess suitability for the study. The evening before bariatric surgery, one month and six months after bariatric surgery anthropometric parameters measurements, blood sampling for blood chemistry routine, inflammatory and lipid-metabolomic profile, and evaluation of any adverse events are performed. For the study samples are stored identified by a code to be analyzed anonymously. Study interruption criteria are: development of allergic reactions, ketonemia> 1.5 mmol/L, acute gout
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients eligible for bariatric surgery
Key inclusion criteria (2 listed)
- subjects with pathological obesity suitable for bariatric surgery
- Body Mass Index (BMI) range 35-59
Key exclusion criteria (4 listed)
- established diagnoses of a major disease (e.g., diabetes or kidney disease)
- pregnancy or breastfeeding,
- food allergies,
- use of drugs that could affect lipid metabolism
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
Modifications of Endocannabinoid and N-acylethanolamine plasma levels
Time frame: 6 months
These lipid derivatives are involved in control of energy expenditure and lipid metabolism and are measured by LC MS/MS and expressed as nmol/ml plasma
Weight loss as kg, and fat mass reduction as total kg and percent of body mass
Time frame: 6 months
Indicators of the success of the intervention
Changes in fatty acid plasma profile induced by bariatric surgery
Time frame: 6 months
Fatty acid profile affect lipid derivatives. Fatty acid are measured by LC and GC and expressed as nmol/ml plasma
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 2 Aug 2021.
- 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. This study is not recruiting at the moment.
Sebastiano Banni, PhD principal investigator
Università di Cagliari
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 Bariatric Surgery Candidate and Lipid Metabolism Disorders, run by University of Cagliari at 1 site in Italy.
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 2 inclusion and 4 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 2 Aug 2021. 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 Italy. 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?
Modifications of Endocannabinoid and N-acylethanolamine plasma levels (time frame: 6 months). The study lists 3 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 Aug 2021.