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Sphingo-lipotoxicity and Trans-differentiation of Adipose Tissue in Obesity (SFINGOTRANS)

NCT05761145 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 84

Last updated 2023-03-13

No results posted yet for this study

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. 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);
2. 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);
3. 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);
4. 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.

Conditions

Interventions

DIAGNOSTIC_TEST

Blood sample collection

Blood sample collection

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2022-03-23
Completion
2022-03-23

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05761145 on ClinicalTrials.gov