Susceptibility to Infectious Diseases in Obesity (SIDERALE)
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| ClinicalTrials.gov Identifier: NCT05975541 |
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Recruitment Status :
Recruiting
First Posted : August 4, 2023
Last Update Posted : January 30, 2024
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Obesity Type2diabetes Gut Microbiota Chronic Disease | Other: Observational |
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 |
| Estimated Enrollment : | 80 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Susceptibility to Infectious Diseases in Obesity: an Endocrine, Translational, Sociological Evaluation |
| Actual Study Start Date : | October 1, 2023 |
| Estimated Primary Completion Date : | February 25, 2025 |
| Estimated Study Completion Date : | October 1, 2025 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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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. |
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control (patients without chronic infections)
Individuals aged between 18-65 years, presenting obesity (BMI between 30-40 kg/m2) and type 2 diabetes.
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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. |
- 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
- 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)
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05975541
| Contact: Flavia Prodam, Prof.MD | +39 0321 660 693 | flavia.prodam@med.uniupo.it |
| Italy | |
| Maggiore della Carità Hospital | Recruiting |
| Novara, Italy, 28100 | |
| Contact: Flavia Prodam, Prof.MD +39 0321 660 693 flavia.prodam@med.uniupo.it | |
| Responsible Party: | Flavia Prodam, Associated Prof. in Clinical Nutrition and MD, Azienda Ospedaliero Universitaria Maggiore della Carita |
| ClinicalTrials.gov Identifier: | NCT05975541 |
| Other Study ID Numbers: |
CE277/2022 |
| First Posted: | August 4, 2023 Key Record Dates |
| Last Update Posted: | January 30, 2024 |
| Last Verified: | January 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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obesity adult type 2 diabetes |
intestinal microbiota chronic infections immune system |
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Communicable Diseases Infections Obesity Diabetes Mellitus, Type 2 Chronic Disease Overweight Overnutrition Nutrition Disorders |
Body Weight Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Disease Attributes Pathologic Processes |