Susceptibility to Infectious Diseases in Obesity

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Omic signature differences between group of case and group of control — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.

Trial sites (1)

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