Susceptibility to Infectious Diseases in Obesity (SIDERALE)

January 29, 2024 updated by: Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita

Susceptibility to Infectious Diseases in Obesity: an Endocrine, Translational, Sociological Evaluation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Novara, Italy, 28100
        • Recruiting
        • Maggiore della Carità Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
control (patients without chronic infections)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Omic signature differences between group of case and group of control
Time Frame: 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
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
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
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
Time Frame: 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.
changes between time 0 months (basal time) and 12 months (end of the study)
Identification of the oral microbiota
Time Frame: 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
changes in oral microbiota between the two different groups at time 0 months, 6 months and 12 months
Number of white blood cells
Time Frame: 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.
changes in WBC biochemical levels between time 0 months, 6 months and 12 months in both case and control groups
Blood cells count
Time Frame: 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.
changes in blood cells count between time 0 months, 6 months and 12 months in both case and control group
Lipid profile identification
Time Frame: 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.
changes in lipid profile between time 0 months, 6 months and 12 months in both case and control group
Uric acid concentration
Time Frame: 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.
changes in uric acid levels between time 0 months, 6 months and 12 months in both case and control group
Evaluation of urine parameters
Time Frame: 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.
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
Time Frame: 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.
changes in vitamin D levels between time 0 months, 6 months and 12 months in both case and control group
Detection of immunoglobulins
Time Frame: 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.
changes in immunoglobulins profile between time 0 months, 6 months and 12 months in both case and control group
QPE index evaluation
Time Frame: 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.
Changes in QPE index level between time 0 months, 6 months and 12 months in both case and control group
Concentration of electrolyte levels
Time Frame: 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.
Changes in the electrolyte levels between time 0 months, 6 months and 12 months in both case and control group
Detection of haptoglobins level
Time Frame: 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.
Changes in haptoglobins levels between time 0 months, 6 months and 12 months in both case and control group
Fecal calprotectin levels identification
Time Frame: 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.
Changes in fecal calprotectin levels between time 0 months, 6 months and 12 months in both case and control group

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body weight monitoring
Time Frame: changes between time 0 months and time 12 months
observation of body weight differences in both case and control groups.
changes between time 0 months and time 12 months
BMI classification
Time Frame: change in BMI classification between time 0 months (basal) and 12 months (end of the study)
individuals will be obese and therefore classify based on BMI, during the study this classification could be change
change in BMI classification between time 0 months (basal) and 12 months (end of the study)
evaluation of waist and hip circumference
Time Frame: changes between time 0 months. 6 months and 12 months
changes in waist and hip circumference in both groups
changes between time 0 months. 6 months and 12 months
assessment of dietary habits
Time Frame: changes in dietary habits between time 0 and time 12 months.

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
changes in dietary habits between time 0 and time 12 months.
assessment of the circadian rhythm trough MEQ questionnaire
Time Frame: changes in circadian rhythm between time 0 months, 6 months and 12 months

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.
changes in circadian rhythm between time 0 months, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

February 25, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE277/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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