Bronchial Asthma and Diabetes: Impact on Bronchial Inflammation and Exercise Capacity

Study Overview
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Brief Summary
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Type 2 diabetes is the most common form of diabetes and according to several studies, even lung can represent another target of the diabetic disease. Asthmatic patients often show comorbidities and obesity is one of the main.Several studies in literature suggest that patients with higher Body Mass Index (i.e. overweight and obese) have a greater risk of developing asthma compared to normal weight subjects. Considering inflammation, asthma is usually characterized by an increase of eosinophils in the airways and by a Th2 type inflammation, while a immunological type Th1 switch systemically characterizes diabetes. Even asthmatic patients, especially if diabetic, might have an increase of glucose in their airways, that could favourite or feed an inflammatory/infective state. Up to-day there are not in literature studies that have investigated the airways inflammatory pattern and the exercise capacity in relation to functional characteristics in diabetic patients affected by asthma.

Detailed Description
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The basic therapy for asthma treatment involves the use of corticosteroids that can lead to the development of glucose intolerance and to the onset of diabetes. Moreover, several works in literature highlight the fact that patients with diagnosis of both asthma and diabetes have a scarcer glycaemic control, a reduced life expectancy, and a higher risk of pneumonia when compared to patients with only asthma or only diabetes. However, in the last years the evaluation of the inflammatory patterns in asthmatic patients has revealed a heterogeneity of the inflammation, with patients characterized by neutrophilic phenotype, mixed granulocytic or without a well-defined inflammatory component (pauci-granulocytic phenotype).On the other side, a immunological type Th1 switch systemically characterizes diabetes. The impact of diabetes, therefore, as a comorbidity in asthmatic patients could influence the inflammatory status of airways. Moreover, studies have reported that glucose is higher in the airways of subjects affected by chronic obstructive pulmonary disease and it correlates with bacterial and viral load compared to healthy controls. Even asthmatic patients, especially if diabetic, might have an increase of glucose in their airways, that could favourite or feed an inflammatory/infective state. Although physical exercise is able to reduce the level of systemic inflammation, improving asthma symptoms and glycaemic control, it is well known that asthmatic and diabetic patients tend to lead a more sedentary life style compared to healthy subjects.A limiting factor that bonds the two pathologies is obesity, since the gain of weight causes exacerbation of respiratory symptoms, resulting in lower effort tolerance. Up to-day there are not in literature studies that have investigated the airways inflammatory pattern and the exercise capacity in relation to functional characteristics in diabetic patients affected by asthma. Aim of the study is to characterize the airways inflammatory pattern of patients affected by bronchial asthma, patients affected by type II diabetes and patients with concomitant diagnosis of asthma and diabetes by using induced sputum. Secondary objective is to characterize the exercise capacity in relation to the functional and anthropometric characteristics of patients with diabetes, with asthma and diabetes, compared to patients with only asthma.

Official Title
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Bronchial Asthma and Diabetes: Impact on Bronchial Inflammation and Exercise Capacity

Conditions
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Asthma, Diabete Type 2

Intervention / Treatment
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* Other: data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of bronchial asthma according to the GINA 2018 guideline Clinical stability of asthmatic disease Diagnosis of Type II diabetes according to the last Italian guidelines (1) and HbA1c < 9%, 54-75mmol/mol Concomitant diagnosis of bronchial asthma (12) and diabetes according to the described guidelines Age ≥18 years Not-smokers, smokers or ex-smokers with pack/year ≤10 Patients able to collaborate in the required procedures and who have signed the informed consent Exclusion criteria: Bronchial asthma and/or diabetes with scarce clinical control. Diagnosis of cognitive impairment Not able to carry out study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| G1 Asthma<br>Diagnosis of bronchial asthma according to the Global Initiative for Asthma (GINA) 2018 guideline Clinical stability of asthmatic disease Age ≥18 years Not-smokers, smokers or ex-smokers with pack/year ≤10 | Other: data collection<br>* collection of data about bronchial and systemic inflammation, quality of life, lung function<br>|
| G2 Diabetes<br>Diagnosis of Type II diabetes according to the last Italian guidelines and HbA1c < 9%, 54-75mmol/mol Age ≥18 years Not-smokers, smokers or ex-smokers with pack/year ≤10 | Other: data collection<br>* collection of data about bronchial and systemic inflammation, quality of life, lung function<br>|
| G3 Asthma plus diabetes<br>Concomitant diagnosis of bronchial asthma according to the GINA 2018 guideline, Clinical stability of asthmatic disease and Diagnosis of Type II diabetes according to the last Italian guidelines and HbA1c < 9%, 54-75mmol/mol Age ≥18 years Not-smokers, smokers or ex-smokers with pack/year ≤10 | Other: data collection<br>* collection of data about bronchial and systemic inflammation, quality of life, lung function<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory cells | macrophages%,neutrophils%, eosinophils%, lymphocytes% | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expiratory muscles strength | Maximal inspiratory pressure -MIP, Maximal expiratory pressure -MEP | baseline | 
| Functional capacity of exercise | 6 minutes walking test-6MWT | baseline | 
| Dyspnoea and muscular fatigue | Dyspnoea and muscle fatigue measured with Modified Borg Scale (0-10, where 0 is better) | baseline | 
| peripheral muscle strength | Five Sit to Stand Test-5STS | baseline | 
| Health related Quality of life | St. George Respiratory Questionnaire-SGRQ, scores range from 0 to 100, with higher scores indicating more limitations | baseline | 
| perceived Health state | Chronic Obstructive Pulmonary Disease Assessment test-CAT, Scores range from 0 to 40, with higher scores indicating worse health state | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eosinophils, symptoms, lung