ObesitySFINGOTRANSNCT05761145
Sphingo-lipotoxicity and Trans-differentiation of Adipose Tissue in Obesity (SFINGOTRANS)
An observational study of Obesity and Healthy, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
After recruiting a population of subjects with different metabolic severity (subjects of normal weight and obese patients with and without metabolic syndrome), the objectives of the present research will be: 1. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Blood sample collection
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2021to 23 Mar 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Obese patients (BMI > 35 kg/m2) and age- and sex-matched healthy controls (normal weighted)
Who may be able to join
- obesity (BMI > 35 kg/m2)
- BMI < 25 kg/m2
Who cannot join
- patients/controls treated with anticoagulant and antiplatelet drugs
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Auxologico Italiano, Site Piancavallo
Oggebbio, Verbania, 28824
About this study
Official title: Relationship Between Sphingo-lipotoxicity and Trans-differentiation of Adipose Tissue: Cross-sectional Study in Subjects With Different Dysmetabolic Severity
After recruiting a population of subjects with different metabolic severity (subjects of normal weight and obese patients with and without metabolic syndrome), the objectives of the present research will be:
- determine leukocyte mRNA levels of Cidea (gene associated with BAT functional status), Hoxc9 (gene associated with browning of WAT) and Cpt1a (gene associated with β-oxidation of fatty acids in both tissues, i.e. BAT and WAT) (secondary endpoint);
- to determine energy expenditure with indirect calorimetric technique, body temperature and circulating catecholamine levels, which will be correlated to leukocyte levels of Cidea, Hoxc9 and Cpt1a mRNA (secondary endpoint);
- determine the plasma levels of an extensive panel of sphingolipids, including in particular ceramides and sphingosine-1-phosphate which, by exerting a lipotoxic, lipoinflammatory and anti-adipogenic effect, will be correlated to the leukocyte levels of Cidea, Hoxc9 mRNA and Cpt1a (primary endpoint);
- determine the erythrocyte, leukocyte and platelet levels of sphingolipids which, acting as peripheral biomarkers of cardiometabolic dysfunction (e.g., atherogenesis, thromboembolism, arterial hypertension, insulin resistance, low-grade chronic inflammation, etc.), could phenotypically identify patients with increased cardiovascular risk (e.g., obese patients with or without metabolic syndrome) (secondary endpoint).
Hypothesis: the existence of a relationship between sphingohypotoxicity and transdifferentiation of adipose tissue and a combination of sphingolipids (plasma/erythrocyte/platelet/leukocyte) and gene regulators (WAT/BAT-related) which, with sensitivity and specificity, is associated with diagnosis of metabolic syndrome.
Read the detailed description
Materials and methods Patients: 90 adults of both sexes will be recruited, of whom 30 of normal weight (age: 18-50 years; BMI < 25 kg/m2), 30 obese without metabolic syndrome (age: 18-35 years; BMI > 35 kg/m2) and 30 obese with metabolic syndrome (age: 18-35 years; BMI > 35 kg/m2), according to the 2009 IDF criteria. Subjects of normal weight will be recruited from medical/paramedical staff, while obese patients from hospitalized at the Division of Metabolic Diseases, Istituto Auxologico Italiano, Piancavallo (VB), Italy, for a 3-week multidisciplinary weight reduction program (BWRP), which includes low-calorie diet, physical exercise, psychological support and nutrition education.
Subjects with other pathologies other than obesity will be excluded from the study, including those treated with anticoagulant and antiplatelet drugs, since the evaluation of intraplatelet levels of sphingolipids will be foreseen.
In basal conditions, the main anthropometric data will be collected (weight, height, waist circumference, hip circumference, BMI), body composition will be evaluated with a bioimpedance technique, the main cardiovascular parameters will be recorded (blood pressure and heart rate), a calorimetric examination will be performed, collection of body temperature (morning and evening), request of the environmental temperature to which one is generally exposed during the day and determined, with automated clinical biochemistry techniques, the following biochemical parameters: glucose, total cholesterol, triglycerides, LDL, HDL, fatty acids non-esterified, insulin, glycated Hb, catecholamines and C-reactive protein.
Determination of the lipidomic profile in plasma and cell extracts A lipidomics will be performed in plasma and in cellular extracts from erythrocytes, leukocytes and platelets. The levels of the individual analytes will be determined with a technologically advanced analytical instrumentation, consisting of a triple quadruple hybrid mass spectrometer with linear ion trap (QTRAP 5500, AB Sciex), interfaced with an ultra-high performance liquid chromatograph (UHPLC).
Plasma and cellular levels of the following sphingolipids will be measured: ceramides and dihydroceramides from C16 to C24, including 2 unsaturated ones (C18:1 and C24:1), the sphingomyelins (those from C16 to C24 and the one C24:1), sphingosine, sphinganine , sphingosine-1-phosphate and sphinganine-1-phosphate.
Determination of leukocyte mRNA levels of gene regulators From an aliquot containing leukocytes, stored ad hoc, the total mRNA will be extracted and, with RT/PCR technique, the leukocyte mRNA levels of the following genes will be determined: Cidea, Hoxc9 and Cpt1a.
- Being tested
- Blood sample collection
- Keywords
- Obesity, Normals, Adipose tissue, Sphyngolipids, Metabolic syndrome
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionDiagnostic test
Blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Cases - obese with metabolic syndrome | Obese subjects with metabolic syndrome Receives: Diagnostic Test: Blood sample collection | |
| Cases - obese without metabolic syndrome | Obese subjects without metabolic syndrome Receives: Diagnostic Test: Blood sample collection | |
| Controls | Normal weight subjects Receives: Diagnostic Test: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sphingolipids
Determination of an extensive panel of sphingolipids, including ceramides and sphingosine-1-phosphate which, by exerting a lipotoxic, lipoinflammatory and anti-adipogenic effect, are correlated to the leukocyte levels of Cidea, Hoxc9 mRNA and Cpt1a
Measured: Baseline
Secondary outcomes (2)
Determination of leukocyte mRNA levels of Cidea and Cpt1a
determination of leukocyte mRNA levels of Cidea (gene associated with BAT functional status), Hoxc9 (gene associated with browning of WAT) and Cpt1a (gene associated with β-oxidation of fatty acids in both tissues, i.e. BAT and WAT)
Measured: Baseline
Determination of the erythrocyte, leukocyte and platelet levels of sphingolipids
Determination of the erythrocyte, leukocyte and platelet levels of sphingolipids which, acting as peripheral biomarkers of cardiometabolic dysfunction (e.g., atherogenesis, thromboembolism, arterial hypertension, insulin resistance, low-grade chronic inflammation, etc.), could phenotypically identify patients with increased cardiovascular risk (e.g., obese patients with or without metabolic syndrome)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start15 Jun 2021
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
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 Istituto Auxologico ItalianoThe 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761145
- Sponsor's protocol ID
- 01C126
- Acronym
- SFINGOTRANS
- Status last verified
- Mar 2023
- First submitted
- 27 Feb 2023
- Last updated
- 13 Mar 2023
- 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 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Sphingo-lipotoxicity and Trans-differentiation of Adipose Tissue: Cross-sectional Study in Subjects With Different Dysmetabolic Severity
- ClinicalTrials.gov ID
- NCT05761145
- Acronym / sponsor ID
- SFINGOTRANS / 01C126
- Keywords
- Obesity, Normals, Adipose tissue, Sphyngolipids, Metabolic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 9 Mar 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.
After recruiting a population of subjects with different metabolic severity (subjects of normal weight and obese patients with and without metabolic syndrome), the objectives of the present research will be:
- determine leukocyte mRNA levels of Cidea (gene associated with BAT functional status), Hoxc9 (gene associated with browning of WAT) and Cpt1a (gene associated with β-oxidation of fatty acids in both tissues, i.e. BAT and WAT) (secondary endpoint);
- to determine energy expenditure with indirect calorimetric technique, body temperature and circulating catecholamine levels, which will be correlated to leukocyte levels of Cidea, Hoxc9 and Cpt1a mRNA (secondary endpoint);
- determine the plasma levels of an extensive panel of sphingolipids, including in particular ceramides and sphingosine-1-phosphate which, by exerting a lipotoxic, lipoinflammatory and anti-adipogenic effect, will be correlated to the leukocyte levels of Cidea, Hoxc9 mRNA and Cpt1a (primary endpoint);
- determine the erythrocyte, leukocyte and platelet levels of sphingolipids which, acting as peripheral biomarkers of cardiometabolic dysfunction (e.g., atherogenesis, thromboembolism, arterial hypertension, insulin resistance, low-grade chronic inflammation, etc.), could phenotypically identify patients with increased cardiovascular risk (e.g., obese patients with or without metabolic syndrome) (secondary endpoint).
Hypothesis: the existence of a relationship between sphingohypotoxicity and transdifferentiation of adipose tissue and a combination of sphingolipids (plasma/erythrocyte/platelet/leukocyte) and gene regulators (WAT/BAT-related) which, with sensitivity and specificity, is associated with diagnosis of metabolic syndrome.
Detailed description
Materials and methods Patients: 90 adults of both sexes will be recruited, of whom 30 of normal weight (age: 18-50 years; BMI < 25 kg/m2), 30 obese without metabolic syndrome (age: 18-35 years; BMI > 35 kg/m2) and 30 obese with metabolic syndrome (age: 18-35 years; BMI > 35 kg/m2), according to the 2009 IDF criteria. Subjects of normal weight will be recruited from medical/paramedical staff, while obese patients from hospitalized at the Division of Metabolic Diseases, Istituto Auxologico Italiano, Piancavallo (VB), Italy, for a 3-week multidisciplinary weight reduction program (BWRP), which includes low-calorie diet, physical exercise, psychological support and nutrition education.
Subjects with other pathologies other than obesity will be excluded from the study, including those treated with anticoagulant and antiplatelet drugs, since the evaluation of intraplatelet levels of sphingolipids will be foreseen.
In basal conditions, the main anthropometric data will be collected (weight, height, waist circumference, hip circumference, BMI), body composition will be evaluated with a bioimpedance technique, the main cardiovascular parameters will be recorded (blood pressure and heart rate), a calorimetric examination will be performed, collection of body temperature (morning and evening), request of the environmental temperature to which one is generally exposed during the day and determined, with automated clinical biochemistry techniques, the following biochemical parameters: glucose, total cholesterol, triglycerides, LDL, HDL, fatty acids non-esterified, insulin, glycated Hb, catecholamines and C-reactive protein.
Determination of the lipidomic profile in plasma and cell extracts A lipidomics will be performed in plasma and in cellular extracts from erythrocytes, leukocytes and platelets. The levels of the individual analytes will be determined with a technologically advanced analytical instrumentation, consisting of a triple quadruple hybrid mass spectrometer with linear ion trap (QTRAP 5500, AB Sciex), interfaced with an ultra-high performance liquid chromatograph (UHPLC).
Plasma and cellular levels of the following sphingolipids will be measured: ceramides and dihydroceramides from C16 to C24, including 2 unsaturated ones (C18:1 and C24:1), the sphingomyelins (those from C16 to C24 and the one C24:1), sphingosine, sphinganine , sphingosine-1-phosphate and sphinganine-1-phosphate.
Determination of leukocyte mRNA levels of gene regulators From an aliquot containing leukocytes, stored ad hoc, the total mRNA will be extracted and, with RT/PCR technique, the leukocyte mRNA levels of the following genes will be determined: Cidea, Hoxc9 and Cpt1a.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cases - obese with metabolic syndrome | – | Diagnostic Test: Blood sample collectionObese subjects with metabolic syndrome |
| Cases - obese without metabolic syndrome | – | Diagnostic Test: Blood sample collectionObese subjects without metabolic syndrome |
| Controls | – | Diagnostic Test: Blood sample collectionNormal weight subjects |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Obese patients (BMI > 35 kg/m2) and age- and sex-matched healthy controls (normal weighted)
Key inclusion criteria (2 listed)
- obesity (BMI > 35 kg/m2)
- BMI < 25 kg/m2
Key exclusion criteria (1 listed)
- patients/controls treated with anticoagulant and antiplatelet drugs
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 |
|---|---|---|
| Blood sample collectionBlood sample collection | Diagnostic test | Cases - obese with metabolic syndrome, Cases - obese without metabolic syndrome, Controls |
Primary outcome
Evaluation of sphingolipids
Time frame: Baseline
Determination of an extensive panel of sphingolipids, including ceramides and sphingosine-1-phosphate which, by exerting a lipotoxic, lipoinflammatory and anti-adipogenic effect, are correlated to the leukocyte levels of Cidea, Hoxc9 mRNA and Cpt1a
2 secondary outcomes
Determination of leukocyte mRNA levels of Cidea and Cpt1a
Time frame: Baseline
Determination of the erythrocyte, leukocyte and platelet levels of sphingolipids
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 13 Mar 2023.
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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.
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 Obesity and Healthy, run by Istituto Auxologico Italiano 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 1 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 13 Mar 2023. 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?
Evaluation of sphingolipids (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 13 Mar 2023.