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

Plain-language summary

This study investigates susceptibility to infectious diseases in people with obesity and explores the effect of a Mediterranean diet and melatonin supplementation. It enrolls people with a body mass index of 30-35 kg/m2 who have various forms of obesity, including genetic obesity and obesity associated with type 2 diabetes or endocrine disorders. The study does not use a phase designation and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Federico II University

Intervention

Mediterranean diet, Melatonin supplementation

Start date

12/29/2023

Estimated completion

10/29/2026

Countries

Italy

Related genes

Locations

• Naples, Italy
• Novara, Italy
• Pisa, Italy
• Roma, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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