NCT05761145

Brief 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. 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. 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. 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

February 27, 2023

Last Update Submit

March 9, 2023

Conditions

ObesityHealthy

Keywords

ObesityNormalsAdipose tissueSphyngolipidsMetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Secondary Outcomes (2)

  • Determination of leukocyte mRNA levels of Cidea and Cpt1a

    Baseline

  • Determination of the erythrocyte, leukocyte and platelet levels of sphingolipids

    Baseline

Study Arms (3)

Cases - obese with metabolic syndrome

Obese subjects with metabolic syndrome

Diagnostic Test: Blood sample collection

Cases - obese without metabolic syndrome

Obese subjects without metabolic syndrome

Diagnostic Test: Blood sample collection

Controls

Normal weight subjects

Diagnostic Test: Blood sample collection

Interventions

Blood sample collectionDIAGNOSTIC_TEST

Blood sample collection

Cases - obese with metabolic syndromeCases - obese without metabolic syndromeControls

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Obese patients (BMI \> 35 kg/m2) and age- and sex-matched healthy controls (normal weighted)

You may qualify if:

  • \- obesity (BMI \> 35 kg/m2)
  • \- BMI \< 25 kg/m2

You may not qualify if:

  • \- patients/controls treated with anticoagulant and antiplatelet drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 9, 2023

Study Start

June 15, 2021

Primary Completion

March 23, 2022

Study Completion

March 23, 2022

Last Updated

March 13, 2023

Record last verified: 2023-03

Locations

IT(1)