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

Launched by FEDERICO II UNIVERSITY · Jan 24, 2024

Keywords

ClinConnect Summary

The clinical trial, called "SIDERALE," is studying how obesity and related conditions, like type 2 diabetes and infections, affect people's immune systems. The researchers want to understand if changes in diet and taking melatonin, a hormone that helps regulate sleep, can improve the body’s ability to fight infections in people with obesity. The trial will involve three groups of patients: those with essential obesity, those with obesity and type 2 diabetes, and those with genetic forms of obesity, along with a group of patients with lipodystrophy, a condition where the body doesn’t store fat properly.

To participate, individuals should be aged between 65 and 74, have a body mass index (BMI) between 30 and 35, and meet specific criteria related to their obesity or other health conditions. Participants can expect a 24-week program that starts with a Mediterranean diet and later includes melatonin. Throughout the study, researchers will monitor how often participants get infections and will also look at their immune responses. This research could provide valuable insights into how lifestyle changes can help improve health outcomes for people with obesity.

Gender

ALL

Eligibility criteria

• 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