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

RecruitingNAAges 18 Years - 65 YearsAllFederico II University
NCT06236932 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 patter

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📋 Eligibility rules (as published)
Inclusion Criteria: * essential obesity (BMI : 30-35 Kg/m2) * genetic forms of obesity (BMI: 30-35 Kg/m2) * obesity (BMI:30-35 Kg/m2) associated with T2DM * obesity (BMI:30-35 Kg/m2) associated with endocrinopathies * lipodystrophy Exclusion Criteria: * pregnancy, breast-feeding, alcohol and drug abuse, known severe haematological, cardiac, liver, kidney, mental diseases, hypogonadisms, hormonal treatments including estroprogestins, intolerance to melatonin or excipients
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What it tests

  • Mediterranean diet
  • Melatonin supplementation
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Where

4 sites
"Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and Oncology
Naples, Italy
Università del Piemonte Orientale
Novara, Italy
University of Pisa
Pisa, Italy
"Sapienza" University of Rome
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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