Investigating gut microbiota in obese patients with type 2 diabetes and infections
Official title: Susceptibility to Infectious Diseases in Obesity: an Endocrine, Translational, Sociological Evaluation
Run by Azienda Ospedaliero Universitaria Maggiore della Carita · NCT05975541 · Data updated 2026-11-12
This study looks at how the bacteria in the gut of obese adults with type 2 diabetes might affect their chances of getting chronic infections.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita Academic / other |
| Locations | 1 site (Novara, Novara) |
| Status | Recruiting |
| Started | October 1, 2023 |
| Main results expected | January 31, 2027 |
| Study ends | May 30, 2027 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT05975541 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-65 with obesity (BMI 30-40 kg/m2) and type 2 diabetes, who may or may not have chronic infections.
✕Probably not a fit
Patients with psychological conditions affecting comprehension, those undergoing specific diet regimens, or with severe immunodepression are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the relationship between gut microbiota composition and susceptibility to chronic infections in patients with obesity and type 2 diabetes (T2D). It will compare the gut microbiota profiles of individuals with and without chronic infections, focusing on how these profiles may influence immune system regulation. The study will include adults aged 18-65 with a BMI between 30-40 kg/m2, and will assess the impact of obesity and T2D on chronic inflammation and infection risk.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of how gut microbiota influences infection susceptibility in obese patients with type 2 diabetes, potentially guiding new therapeutic strategies.
How similar studies have gone: While the role of gut microbiota in obesity and diabetes is an emerging field, this specific investigation into its connection with chronic infections is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Maggiore della Carità Hospital
Novara, Novara, Italy Recruiting
Study contacts
- Study coordinator: Flavia Prodam, Prof.MD
- Email: flavia.prodam@med.uniupo.it
- Phone: +39 0321 660 693
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.