- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04448262
Bronchial Asthma and Diabetes: Impact on Bronchial Inflammation and Exercise Capacity
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lombardia
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Tradate, Lombardia, Italy, 21049
- Istituti Clinici Maugeri Pneumologia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
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collection of data about bronchial and systemic inflammation, quality of life, lung function
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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
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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
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collection of data about bronchial and systemic inflammation, quality of life, lung function
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
inflammatory cells
Time Frame: baseline
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macrophages%,neutrophils%, eosinophils%, lymphocytes%
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expiratory muscles strength
Time Frame: baseline
|
Maximal inspiratory pressure -MIP, Maximal expiratory pressure -MEP
|
baseline
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Functional capacity of exercise
Time Frame: baseline
|
6 minutes walking test-6MWT
|
baseline
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Dyspnoea and muscular fatigue
Time Frame: baseline
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Dyspnoea and muscle fatigue measured with Modified Borg Scale (0-10, where 0 is better)
|
baseline
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peripheral muscle strength
Time Frame: baseline
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Five Sit to Stand Test-5STS
|
baseline
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Health related Quality of life
Time Frame: baseline
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St. George Respiratory Questionnaire-SGRQ, scores range from 0 to 100, with higher scores indicating more limitations
|
baseline
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perceived Health state
Time Frame: baseline
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Chronic Obstructive Pulmonary Disease Assessment test-CAT, Scores range from 0 to 40, with higher scores indicating worse health state
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baseline
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Antonio Spanevello, Prof, ICS Maugeri
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Endocrine System Diseases
- Diabetes Mellitus
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Diabetes Mellitus, Type 2
- Inflammation
- Asthma
Other Study ID Numbers
- 2290 CE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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