ObesitySIDERALENCT05975541
Susceptibility to Infectious Diseases in Obesity
An observational study of Obesity and Type2diabetes, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type2diabetes, Gut Microbiota
- What is being tested?
- Observational
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2023to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- oncological and hematological pathologies
- Hypogonadism
- severe immunodepression
- vaccination in the last two weeks
- Alcohol or drug abuse
- antibiotic therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Maggiore della Carità Hospital
Novara, Novara, 28100
Flavia Prodam, Prof.MD, +39 0321 660 693, flavia.prodam@med.uniupo.it
About this study
Official title: Susceptibility to Infectious Diseases in Obesity: an Endocrine, Translational, Sociological Evaluation
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.
Read the detailed description
Obesity is nowadays a relevant public issue, with more than 650 million people affected worldwide. By definition, obesity is characterized by excessive calorie intake and lowering energy expenditure favored today by the increased sedentary lifestyle and junk food availability. Obesity represents a risk factor for cardiovascular diseases, neoplasm, and first of all type II diabetes. Nonetheless, obesity increases susceptibility to infectious disorders such as urinary tract infections, periodontitis, herpes virus infection, and also Covid-19. During the pandemic, obese patients were interested in the severe form of Covid-19 and also they presented less response to the vaccine.
Because of insulin resistance and chronic inflammation, typical of obese patients, T2D is a classical comorbidity presented by these individuals. Together these two pathologies lead to immune system deregulation and a high predisposition to secondary infections. A third player is the gut microbiota, recent discoveries demonstrated as intestinal microbiota is strictly interconnected with obesity and diabetes and with the circadian clock. Being the gut microbiota an important regulator of the immune system changes in gut microbiota composition induced by diet, obesity, and T2D can be reflected in the impairment of the immune system.
The purpose of the present study is the investigation of the gut microbiota signature in patients presenting obesity and T2D with or without infectious diseases. The idea is the identification of microbiota composition about pathological, metabolomic, and socio-economic features. Obtained results from this study could be used for the identification of new therapeutic targets involved in the development of these pathologies.
- Conditions
- Obesity, Type2diabetes, Gut Microbiota, Chronic Disease
- Being tested
- Observational
- Keywords
- obesity, adult, type 2 diabetes, intestinal microbiota, chronic infections, immune system
- Medical subject headings
- Obesity, Chronic Disease, Diabetes Mellitus, Type 2, Persistent Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| case (patients having chronic infections) | Individuals aged between 18-65 years, presenting obesity (BMI between 30-40 kg/m2), type 2 diabetes, and chronic infections (i.e. urinary tract infections, periodontitis, herpetic infections) at the basal time. Receives: Other: Observational | |
| control (patients without chronic infections) | Individuals aged between 18-65 years, presenting obesity (BMI between 30-40 kg/m2) and type 2 diabetes. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omic signature differences between group of case and group of control
it is expected to find differences in the signature of the gut microbiota between patients with chronic infections and those not having infections
Measured: 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
DIfferences among pro-inflammatory cytokines (IL-6, IL-1, IL-10, IL-17, IL-18, TNF-alpha)
Measured: 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 in pharmacological therapy for the treatment of diabetes, obesity, or concomitant infections due to aggravation or resolution of the pathology will be investigated through the use of a patient card.
Measured: changes between time 0 months (basal time) and 12 months (end of the study)
Identification of the oral microbiota
collection of oral microbiota by swab both in the control group and in the case
Measured: changes in oral microbiota between the two different groups at time 0 months, 6 months and 12 months
Number of white blood cells
Use of the leucocyte formula for evaluating the number of white blood cells (WBC) in the patient's blood in both case and group.
Measured: changes in WBC biochemical levels between time 0 months, 6 months and 12 months in both case and control groups
Blood cells count
Evaluation of the blood cells with particular attention to the red blood cells in both control and case groups.
Measured: changes in blood cells count between time 0 months, 6 months and 12 months in both case and control group
Lipid profile identification
Evaluation of the total cholesterol, LDL, and triglycerides through blood sample collection in both case and control groups.
Measured: changes in lipid profile between time 0 months, 6 months and 12 months in both case and control group
Uric acid concentration
Evaluation of the levels of uric acid through blood sample collection in patients.
Measured: changes in uric acid levels between time 0 months, 6 months and 12 months in both case and control group
Evaluation of urine parameters
Detection of the levels of microalbuminuria and creatinuria in patients of both group through urine collection and analysis.
Measured: changes in microalbuminuria and creatinuria levels between time 0 months, 6 months and 12 months in both case and control group
Concentration of vitamin D
Detection of Vitamin D levels in patients, through blood sample collection.
Measured: changes in vitamin D levels between time 0 months, 6 months and 12 months in both case and control group
Detection of immunoglobulins
Total immunoglobulins evaluation (IgE, IgA, IgD, IgG, IgM) in patients through blood sample collection. The analysis will be performed on both case and control groups.
Measured: changes in immunoglobulins profile between time 0 months, 6 months and 12 months in both case and control group
QPE index evaluation
Evaluation of album, alpha-1 globulin, alpha-2 globulin, beta-globulin, and gamma-globulin through protein electrophoresis (QPE) in both case and control groups.
Measured: Changes in QPE index level between time 0 months, 6 months and 12 months in both case and control group
Concentration of electrolyte levels
Detection of phosphorus and calcium levels in patients, through blood sample collection of both case and control groups.
Measured: Changes in the electrolyte levels between time 0 months, 6 months and 12 months in both case and control group
Detection of haptoglobins level
Evaluation of the haptoglobins levels in patients through blood sample collection.
Measured: Changes in haptoglobins levels between time 0 months, 6 months and 12 months in both case and control group
Fecal calprotectin levels identification
Detection of fecal calprotectin levels in stool samples collected from patients in both groups.
Measured: Changes in fecal calprotectin levels between time 0 months, 6 months and 12 months in both case and control group
Secondary outcomes (5)
body weight monitoring
observation of body weight differences in both case and control groups.
Measured: changes between time 0 months and time 12 months
BMI classification
individuals will be obese and therefore classify based on BMI, during the study this classification could be change
Measured: change in BMI classification between time 0 months (basal) and 12 months (end of the study)
evaluation of waist and hip circumference
changes in waist and hip circumference in both groups
Measured: changes between time 0 months. 6 months and 12 months
assessment of dietary habits
identification of dietary habits in control groups and in the case group. Detection of the differences in the dietary habits between the two groups through the use of some specific and validated questionnaires (24h recall and Predimed).
A 24-hour dietary recall (24HR) questionnaire to provides information about the consumption of food groups of particular interest, such as the total intake of fruits, vegetables, or added sugars.
Predimed is a questionnaire based on adherence to the Mediterranean Diet. There is a final score that allows to identify those patients that follow this kind of nutritional regimen. Each question (if true for Mediterranean Diet) gives 1 point; the final score is structured as follows:
≤5 Low adherence 6 - 9= medium adherence >10 good adherence
Measured: changes in dietary habits between time 0 and time 12 months.
assessment of the circadian rhythm trough MEQ questionnaire
Detection of the circadian rhythm through the Morningness Eveningness Questionnaire (MEQ) in patients of both control and case groups.
MEQ is a self-assessment questionnaire developed to measure whether a person's circadian rhythm (biological clock) produces peak alertness in the morning, in the evening, or in between.
The standard MEQ consists of 19 multiple-choice questions, each having four or five response options.
Responses to the questions are combined to form a composite score that indicates the degree to which the respondent favors morning versus evening. The score is in a range between 16 and 86. If the score is lower or equal to 41 the patient is classified as an "evening" type; equal to or higher than 59, the patient is a "morning" type; between 42 and 58 is a "middle" phenotype.
Measured: changes in circadian rhythm between time 0 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Oct 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975541
- Sponsor's protocol ID
- CE277/2022
- Acronym
- SIDERALE
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Susceptibility to Infectious Diseases in Obesity: an Endocrine, Translational, Sociological Evaluation
- ClinicalTrials.gov ID
- NCT05975541
- Acronym / sponsor ID
- SIDERALE / CE277/2022
- Conditions
- Obesity, Type2diabetes, Gut Microbiota, Chronic Disease
- Keywords
- obesity, adult, type 2 diabetes, intestinal microbiota, chronic infections, immune system
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity is nowadays a relevant public issue, with more than 650 million people affected worldwide. By definition, obesity is characterized by excessive calorie intake and lowering energy expenditure favored today by the increased sedentary lifestyle and junk food availability. Obesity represents a risk factor for cardiovascular diseases, neoplasm, and first of all type II diabetes. Nonetheless, obesity increases susceptibility to infectious disorders such as urinary tract infections, periodontitis, herpes virus infection, and also Covid-19. During the pandemic, obese patients were interested in the severe form of Covid-19 and also they presented less response to the vaccine.
Because of insulin resistance and chronic inflammation, typical of obese patients, T2D is a classical comorbidity presented by these individuals. Together these two pathologies lead to immune system deregulation and a high predisposition to secondary infections. A third player is the gut microbiota, recent discoveries demonstrated as intestinal microbiota is strictly interconnected with obesity and diabetes and with the circadian clock. Being the gut microbiota an important regulator of the immune system changes in gut microbiota composition induced by diet, obesity, and T2D can be reflected in the impairment of the immune system.
The purpose of the present study is the investigation of the gut microbiota signature in patients presenting obesity and T2D with or without infectious diseases. The idea is the identification of microbiota composition about pathological, metabolomic, and socio-economic features. Obtained results from this study could be used for the identification of new therapeutic targets involved in the development of these pathologies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case (patients having chronic infections) | – | Other: ObservationalIndividuals aged between 18-65 years, presenting obesity (BMI between 30-40 kg/m2), type 2 diabetes, and chronic infections (i.e. urinary tract infections, periodontitis, herpetic infections) at the basal time. |
| control (patients without chronic infections) | – | Other: ObservationalIndividuals aged between 18-65 years, presenting obesity (BMI between 30-40 kg/m2) and type 2 diabetes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalNo 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. | Other | case (patients having chronic infections), control (patients without chronic infections) |
Primary outcome
Omic signature differences between group of case and group of control
Time frame: Changes in microbiota composition between time 0 months (start point of the study) and 12 months (end point of the study)
it is expected to find differences in the signature of the gut microbiota between patients with chronic infections and those not having infections
Immune system differences between group of case and group of control
Time frame: 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
DIfferences among pro-inflammatory cytokines (IL-6, IL-1, IL-10, IL-17, IL-18, TNF-alpha)
Patient card for the evaluation of the pharmacological therapy
Time frame: changes between time 0 months (basal time) and 12 months (end of the study)
Changes in pharmacological therapy for the treatment of diabetes, obesity, or concomitant infections due to aggravation or resolution of the pathology will be investigated through the use of a patient card.
Identification of the oral microbiota
Time frame: changes in oral microbiota between the two different groups at time 0 months, 6 months and 12 months
collection of oral microbiota by swab both in the control group and in the case
Number of white blood cells
Time frame: changes in WBC biochemical levels between time 0 months, 6 months and 12 months in both case and control groups
Use of the leucocyte formula for evaluating the number of white blood cells (WBC) in the patient's blood in both case and group.
Blood cells count
Time frame: changes in blood cells count between time 0 months, 6 months and 12 months in both case and control group
Evaluation of the blood cells with particular attention to the red blood cells in both control and case groups.
Lipid profile identification
Time frame: changes in lipid profile between time 0 months, 6 months and 12 months in both case and control group
Evaluation of the total cholesterol, LDL, and triglycerides through blood sample collection in both case and control groups.
Uric acid concentration
Time frame: changes in uric acid levels between time 0 months, 6 months and 12 months in both case and control group
Evaluation of the levels of uric acid through blood sample collection in patients.
Evaluation of urine parameters
Time frame: changes in microalbuminuria and creatinuria levels between time 0 months, 6 months and 12 months in both case and control group
Detection of the levels of microalbuminuria and creatinuria in patients of both group through urine collection and analysis.
Concentration of vitamin D
Time frame: changes in vitamin D levels between time 0 months, 6 months and 12 months in both case and control group
Detection of Vitamin D levels in patients, through blood sample collection.
Detection of immunoglobulins
Time frame: changes in immunoglobulins profile between time 0 months, 6 months and 12 months in both case and control group
Total immunoglobulins evaluation (IgE, IgA, IgD, IgG, IgM) in patients through blood sample collection. The analysis will be performed on both case and control groups.
QPE index evaluation
Time frame: Changes in QPE index level between time 0 months, 6 months and 12 months in both case and control group
Evaluation of album, alpha-1 globulin, alpha-2 globulin, beta-globulin, and gamma-globulin through protein electrophoresis (QPE) in both case and control groups.
Concentration of electrolyte levels
Time frame: Changes in the electrolyte levels between time 0 months, 6 months and 12 months in both case and control group
Detection of phosphorus and calcium levels in patients, through blood sample collection of both case and control groups.
Detection of haptoglobins level
Time frame: Changes in haptoglobins levels between time 0 months, 6 months and 12 months in both case and control group
Evaluation of the haptoglobins levels in patients through blood sample collection.
Fecal calprotectin levels identification
Time frame: Changes in fecal calprotectin levels between time 0 months, 6 months and 12 months in both case and control group
Detection of fecal calprotectin levels in stool samples collected from patients in both groups.
5 secondary outcomes
body weight monitoring
Time frame: changes between time 0 months and time 12 months
BMI classification
Time frame: change in BMI classification between time 0 months (basal) and 12 months (end of the study)
evaluation of waist and hip circumference
Time frame: changes between time 0 months. 6 months and 12 months
assessment of dietary habits
Time frame: changes in dietary habits between time 0 and time 12 months.
assessment of the circadian rhythm trough MEQ questionnaire
Time frame: changes in circadian rhythm between time 0 months, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Type2diabetes, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flavia Prodam, Prof.MD (+39 0321 660 693, flavia.prodam@med.uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Omic signature differences between group of case and group of control (time frame: Changes in microbiota composition between time 0 months (start point of the study) and 12 months (end point of the study)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.