NCT05975541 Susceptibility to Infectious Diseases in Obesity
| NCT ID | NCT05975541 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita |
| Condition | Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2023-10-01 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05975541 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05975541 currently recruiting?
Yes, NCT05975541 is actively recruiting participants. Contact the research team at flavia.prodam@med.uniupo.it for enrollment information.
Where is the NCT05975541 trial being conducted?
This trial is being conducted at Novara, Italy.
Who is sponsoring the NCT05975541 clinical trial?
NCT05975541 is sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita. The trial plans to enroll 80 participants.
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