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Study identifier: NCT06236932 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Susceptibility to Infectious Diseases in obEsity: an endocRine trAnslational socioLogic Evaluation, "SIDERALE"

Condition: Obesity · Type2diabetes · Lipodystrophy  ·  Sponsor: Federico II University

PhaseNA
Planned participants100
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

Obesity is a life-threatening disease, defined by excessive fat accumulation that increases the risk of other diseases such as cardiovascular events, hypertension, diabetes and cancer. Obesity is also a risk factor for nosocomial infections and is associated with worse COVID-19 outcomes, although anthropometric measurements are not routinely recorded during hospitalization and lack of a registry data does not allow performing retrospective studies.Obesity is closely related to chronodisruption, characterized by deregulation of physiological and behavioral central and peripheral circadian rhythms contributing to the obesity-related metabolic impairment. Eating and sleeping time schedules are relevant synchronizers of humans' biological clock. Several studies suggest a role of dietary interventions in rewiring the circadian rhythm, with Mediterranean diet (MD) regulating nutritional patterns. Moreover, considering its positive impact on sleep quality, melatonin intake was suggested as a potential regulator of circadian rhythms. The relation between chronodisruption, obesity and infections has not been investigated, and a first proof of concept (Pilot study) will aim at investigating it. Three cohorts of obese patients with different aetiology (essential obesity, obesity with type 2 diabetes, genetic forms of obesity) and a cohort of lipodystrophic patients will be enrolled in the study, which is designed as a two-phases protocol. During the first phase (0-12 weeks (w)) patients…

This description comes directly from the study's public registry record.

Talk to the study team

Annamaria Colao, Prof  ·  +393285390000  ·  colao@unina.it

Always discuss trial participation with your own doctor first.

Locations (4)

"Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and OncologyNaples, ItalyRecruiting
Università del Piemonte OrientaleNovara, ItalyRecruiting
University of PisaPisa, ItalyRecruiting
"Sapienza" University of RomeRoma, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06236932