Susceptibility to Infectious Diseases in Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
age between 18-65 years
ability to understand the study protocol
obesity with BMI between 30-40 kg/m2
affects by type II diabetes
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Observational
Other interventionNo 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: case (patients having chronic infections)1 intervention
Group B: control (patients without chronic infections)1 intervention
Trial outcomes
Primary outcomes
1
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)2
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 group3
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)4
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 monthsSecondary outcomes
1
body weight monitoring
observation of body weight differences in both case and control groups.
Time frame
changes between time 0 months and time 12 months2
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)3
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 months4
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.Sponsors and contacts
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Source ClinicalTrials.gov