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Susceptibility to infectious diseases in obesity: an endocrine, translational, sociological evaluation

NCT ID NCT05975541

NEW Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 10, 2026 · Last updated Sep 10, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The population of interest for this study will be recruited by the endocrinology of the hospital "Maggiore della Carità" of Novara. The patients recruited will be equally divided into the two groups according to the presence or not of concurrent infections and will be adequately matched by age, sex, and characteristics in order to maintain a certain homogeneity of the study.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Chronic Disease Obesity obesity disorder Persistent Infection type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic disease Gut microbiota Obesity TYPE2DIABETES

How to take part

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  1. The places running it

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  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Maggiore della Carità Hospital

    RECRUITING

    Novara, Novara, 28100, Italy

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