Susceptibility to Infectious Diseases in Obesity: an Endocrine, Translational, Sociological Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Omic signature differences between group of case and group of control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
control (patients without chronic infections)
Individuals aged between 18-65 years, presenting obesity (BMI between 30-40 kg/m2) and type 2 diabetes.
干预措施: Observational (Other)
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.
干预措施: Observational (Other)
结局指标
主要结局
Omic signature differences between group of case and group of control
时间窗: 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
Concentration of electrolyte levels
时间窗: 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.
Concentration of vitamin D
时间窗: 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.
Patient card for the evaluation of the pharmacological therapy
时间窗: 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
时间窗: 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
Immune system differences between group of case and group of control
时间窗: 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)
Uric acid concentration
时间窗: 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.
Number of white blood cells
时间窗: 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
时间窗: 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
时间窗: 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.
Evaluation of urine parameters
时间窗: 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.
Detection of immunoglobulins
时间窗: 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
时间窗: 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.
Detection of haptoglobins level
时间窗: 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
时间窗: 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.
次要结局
- 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 the circadian rhythm trough MEQ questionnaire(changes in circadian rhythm between time 0 months, 6 months and 12 months)
- assessment of dietary habits(changes in dietary habits between time 0 and time 12 months.)
研究者
Flavia Prodam
Associated Prof. in Clinical Nutrition and MD
Azienda Ospedaliero Universitaria Maggiore della Carita