Clinical trial NCT05975541: Susceptibility to Infectious Diseases in Obesity
Official title: Susceptibility to Infectious Diseases in Obesity: an Endocrine, Translational, Sociological Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Type2diabetes
Gut Microbiota
Chronic Disease
Keywords: obesity
adult
type 2 diabetes
intestinal microbiota
chronic infections
immune system
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Omic signature differences between group of case and group of control
timeFrame: Changes in microbiota composition between time 0 months (start point of the study) and 12 months (end point of the study)
measure: Immune system differences between group of case and group of control
timeFrame: 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
measure: Patient card for the evaluation of the pharmacological therapy
timeFrame: changes between time 0 months (basal time) and 12 months (end of the study)
measure: Identification of the oral microbiota
timeFrame: changes in oral microbiota between the two different groups at time 0 months, 6 months and 12 months
measure: Number of white blood cells
timeFrame: changes in WBC biochemical levels between time 0 months, 6 months and 12 months in both case and control groups
measure: Blood cells count
timeFrame: changes in blood cells count between time 0 months, 6 months and 12 months in both case and control group
measure: Lipid profile identification
timeFrame: changes in lipid profile between time 0 months, 6 months and 12 months in both case and control group
measure: Uric acid concentration
timeFrame: changes in uric acid levels between time 0 months, 6 months and 12 months in both case and control group
measure: Evaluation of urine parameters
timeFrame: changes in microalbuminuria and creatinuria levels between time 0 months, 6 months and 12 months in both case and control group
measure: Concentration of vitamin D
timeFrame: changes in vitamin D levels between time 0 months, 6 months and 12 months in both case and control group
measure: Detection of immunoglobulins
timeFrame: changes in immunoglobulins profile between time 0 months, 6 months and 12 months in both case and control group
measure: QPE index evaluation
timeFrame: Changes in QPE index level between time 0 months, 6 months and 12 months in both case and control group
measure: Concentration of electrolyte levels
timeFrame: Changes in the electrolyte levels between time 0 months, 6 months and 12 months in both case and control group
measure: Detection of haptoglobins level
timeFrame: Changes in haptoglobins levels between time 0 months, 6 months and 12 months in both case and control group
measure: Fecal calprotectin levels identification
timeFrame: Changes in fecal calprotectin levels between time 0 months, 6 months and 12 months in both case and control group
Secondary outcomes:
measure: body weight monitoring
timeFrame: changes between time 0 months and time 12 months
measure: BMI classification
timeFrame: change in BMI classification between time 0 months (basal) and 12 months (end of the study)
measure: evaluation of waist and hip circumference
timeFrame: changes between time 0 months. 6 months and 12 months
measure: assessment of dietary habits
timeFrame: changes in dietary habits between time 0 and time 12 months.
measure: assessment of the circadian rhythm trough MEQ questionnaire
timeFrame: changes in circadian rhythm between time 0 months, 6 months and 12 months
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Maggiore della Carità Hospital
Study officials:
References: