Investigating gut microbiota in obese patients with type 2 diabetes and infections
Susceptibility to Infectious Diseases in Obesity: an Endocrine, Translational, Sociological Evaluation
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 |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita Academic / other |
| Locations | 1 site (Novara) |
| Trial ID | NCT05975541 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Novara
- Maggiore della Carità Hospital — Novara, Italy (Recruiting)
Study contacts
- Study coordinator: Flavia Prodam, Prof.MD
- Email: flavia.prodam@med.uniupo.it
- Phone: +39 0321 660 693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.