Susceptibility to Infectious Diseases in Obesity
SIDERALE
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Oct 2023
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2023
CompletedFirst Posted
Study publicly available on registry
August 4, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJanuary 30, 2024
January 1, 2024
1.4 years
July 12, 2023
January 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
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
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)
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
changes between time 0 months and time 12 months
BMI classification
change in BMI classification between time 0 months (basal) and 12 months (end of the study)
evaluation of waist and hip circumference
changes between time 0 months. 6 months and 12 months
assessment of dietary habits
changes in dietary habits between time 0 and time 12 months.
assessment of the circadian rhythm trough MEQ questionnaire
changes in circadian rhythm between time 0 months, 6 months and 12 months
Study Arms (2)
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.
control (patients without chronic infections)
Individuals aged between 18-65 years, presenting obesity (BMI between 30-40 kg/m2) and type 2 diabetes.
Interventions
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.
Eligibility Criteria
The population of interest for this study will be recruited by the endocrinology of the hospital "Maggiore della CaritĂ " 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.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maggiore della CaritĂ Hospital
Novara, 28100, Italy
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Prof. in Clinical Nutrition and MD
Study Record Dates
First Submitted
July 12, 2023
First Posted
August 4, 2023
Study Start
October 1, 2023
Primary Completion
February 25, 2025
Study Completion
October 1, 2025
Last Updated
January 30, 2024
Record last verified: 2024-01