Recruiting

Susceptibility to Infectious Diseases in Obesity

ClinicalTrials.gov IDNCT05975541

PhaseNot Applicable

Enrollment80

SponsorAzienda Ospedaliero Universitaria Maggiore della Carita

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Obesity, Type2diabetes, Gut Microbiota, Chronic Disease

About this study

The role of intestinal microbiota is becoming ever more important in the context of obesity, type II diabetes (T2D), and infectious disorders as represented by the emerging discipline "therapeutic microbiology". The gut microbiota is strictly interconnected with obesity and T2D playing also an important role in immune system regulation. Obesity and diabetes can lead to chronic inflammation, which results in the secretion of pro-inflammatory cytokines like IL-6, IL-1, and TNF-alpha, causing immune system alteration which predisposes patients with obesity and T2D to chronic infections. Therefore, the principal aim of the study is to investigate changes in gut microbiota composition between patients with chronic infections or not, so as to attribute to specific phyla the formation of the infections in these patients.

Interventions

Other: Observational — No intervention will be carried out in this study. Patients from both groups will be monitored for 12 months through observations at time 0, time 6 months, and 12 months. Questionnaires, good clinical practice samples, and anthropometric measurements will be made to monitor changes in the two groups.

Primary outcomes

Omic signature differences between group of case and group of control (Changes in microbiota composition between time 0 months (start point of the study) and 12 months (end point of the study))
Immune system differences between group of case and group of control (Changes in the level and type of pro-inflammatory cytokines between basal time, 0 months , 6 and 12 months (end of the study) in both case and control group)
Patient card for the evaluation of the pharmacological therapy (changes between time 0 months (basal time) and 12 months (end of the study))
Identification of the oral microbiota (changes in oral microbiota between the two different groups at time 0 months, 6 months and 12 months)
Number of white blood cells (changes in WBC biochemical levels between time 0 months, 6 months and 12 months in both case and control groups)
Blood cells count (changes in blood cells count between time 0 months, 6 months and 12 months in both case and control group)
Lipid profile identification (changes in lipid profile between time 0 months, 6 months and 12 months in both case and control group)
Uric acid concentration (changes in uric acid levels between time 0 months, 6 months and 12 months in both case and control group)

Eligibility information

Inclusion Criteria: * age between 18-65 years * ability to understand the study protocol * obesity with BMI between 30-40 kg/m2 * affects by type II diabetes * presence/absence of chronic infections * the possibility of equality in the two groups (matched for sex, age, and therapies) Exclusion Criteria: * psychological conditions that reduced the ability the comprehension of the study protocol * subjects undergoing a diet-therapeutic regimen; * subjects with the possibility of developing diabetic foot in the successive months * patients with relapsing infections * pregnancy * bariatric surgery * oncological and hematological pathologies * Hypogonadism * severe immunodepression * vaccination in the last two weeks * Alcohol or drug abuse * antibiotic therapy

Study locations

Maggiore della Carità Hospital, Novara, Novara 28100 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.