Clinical trial NCT04448262: Bronchial Asthma and Diabetes: Impact on Bronchial Inflammation and Exercise Capacity
Official title: Bronchial Asthma and Diabetes: Impact on Bronchial Inflammation and Exercise Capacity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
Diabete Type 2
Keywords: eosinophils, symptoms, lung
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: Galmarini Hospital, Tradate
First posted: 2020-06-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asthmatic patients will be evaluated and enrolled during outpatients follow-up visits at the ICS Institute Maugeri of Tradate, type II diabetic patients at the Galmarini Hospital of Tradate, while patients with concomitant diagnosis of asthma and type II diabetes will be evaluated and enrolled and enrolled in both the two structures.

20 patients per group will be the sample size

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: inflammatory cells
timeFrame: baseline
Secondary outcomes:
measure: Expiratory muscles strength
timeFrame: baseline
measure: Functional capacity of exercise
timeFrame: baseline
measure: Dyspnoea and muscular fatigue
timeFrame: baseline
measure: peripheral muscle strength
timeFrame: baseline
measure: Health related Quality of life
timeFrame: baseline
measure: perceived Health state
timeFrame: baseline
Other outcomes:
Locations:
city: Tradate
country: Italy
facility: Istituti Clinici Maugeri Pneumologia
state: Lombardia
Study officials:
affiliation: ICS Maugeri
name: Antonio Spanevello, Prof
role: STUDY_DIRECTOR
References:
citation: Vracko R, Thorning D, Huang TW. Basal lamina of alveolar epithelium and capillaries: quantitative changes with aging and in diabetes mellitus. Am Rev Respir Dis. 1979 Nov;120(5):973-83. doi: 10.1164/arrd.1979.120.5.973.
citation: Visca D, Pignatti P, Spanevello A, Lucini E, La Rocca E. Relationship between diabetes and respiratory diseases-Clinical and therapeutic aspects. Pharmacol Res. 2018 Nov;137:230-235. doi: 10.1016/j.phrs.2018.10.008. Epub 2018 Oct 9.
citation: Cardet JC, Ash S, Kusa T, Camargo CA Jr, Israel E. Insulin resistance modifies the association between obesity and current asthma in adults. Eur Respir J. 2016 Aug;48(2):403-10. doi: 10.1183/13993003.00246-2016. Epub 2016 Apr 21.
citation: Mallia P, Webber J, Gill SK, Trujillo-Torralbo MB, Calderazzo MA, Finney L, Bakhsoliani E, Farne H, Singanayagam A, Footitt J, Hewitt R, Kebadze T, Aniscenko J, Padmanaban V, Molyneaux PL, Adcock IM, Barnes PJ, Ito K, Elkin SL, Kon OM, Cookson WO, Moffat MF, Johnston SL, Tregoning JS. Role of airway glucose in bacterial infections in patients with chronic obstructive pulmonary disease. J Allergy Clin Immunol. 2018 Sep;142(3):815-823.e6. doi: 10.1016/j.jaci.2017.10.017. Epub 2018 Jan 5.