Bronchial Asthma and Diabetes: Impact on Bronchial Inflammation and Exercise Capacity
NCT ID: NCT04448262
Last Updated: 2024-02-08
Study Results
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Basic Information
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TERMINATED
39 participants
OBSERVATIONAL
2019-07-10
2024-01-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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G1 Asthma
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
data collection
collection of data about bronchial and systemic inflammation, quality of life, lung function
G2 Diabetes
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
data collection
collection of data about bronchial and systemic inflammation, quality of life, lung function
G3 Asthma plus diabetes
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
data collection
collection of data about bronchial and systemic inflammation, quality of life, lung function
Interventions
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data collection
collection of data about bronchial and systemic inflammation, quality of life, lung function
Eligibility Criteria
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Inclusion Criteria
* 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
* Diagnosis of cognitive impairment
* Not able to carry out study procedures
18 Years
85 Years
ALL
No
Sponsors
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Galmarini Hospital, Tradate
UNKNOWN
Istituti Clinici Scientifici Maugeri SpA
OTHER
Responsible Party
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Principal Investigators
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Antonio Spanevello, Prof
Role: STUDY_DIRECTOR
ICS Maugeri
Locations
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Istituti Clinici Maugeri Pneumologia
Tradate, Lombardy, Italy
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2290 CE
Identifier Type: -
Identifier Source: org_study_id
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