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NCT05761145: SFINGOTRANS

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

Completed Last updated 13 March 2023
What this trial tests

trial testing Blood sample collection in Obesity in 84 participants. Completed in 23 March 2022.

Timeline
15 June 2021
Primary endpoint
23 March 2022
23 March 2022

Quick facts

Lead sponsorIstituto Auxologico Italiano
StatusCompleted
Study typeOBSERVATIONAL
Enrollment84
Start date15 June 2021
Primary completion23 March 2022
Estimated completion23 March 2022
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Istituto Auxologico Italiano — full company profile →

Who can join

Adults 18 to 50, any sex, with Obesity or Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Blood sample collection

Trials testing the same drug.

Other recruiting trials for Obesity

Currently open trials in the same condition.

Other Istituto Auxologico Italiano trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05761145.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing