An observational study in Obesity, Type2diabetes and Gut Microbiota, sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita · Observational
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 80 is below the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →Azienda Ospedaliero Universitaria Maggiore della Carita is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Observational
Individuals aged between 18-65 years, presenting obesity (BMI between 30-40 kg/m2) and type 2 diabetes.
Other: Observational
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.
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
Time frame: 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)
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
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Changes in fecal calprotectin levels between time 0 months, 6 months and 12 months in both case and control group
body weight monitoring
observation of body weight differences in both case and control groups.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: changes in circadian rhythm between time 0 months, 6 months and 12 months
Started Oct 2023 (actual). Primary completion is estimated for Jan 2027, 39 months after the start.
Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's planned 39 months is close to that.
Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
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Azienda Ospedaliero Universitaria Maggiore della Carita