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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04448262
• Other study ID #: 2290 CE
• Status: Terminated
• Start date: July 10, 2019
• Est. completion date: January 12, 2024

Study information

• Verified date: January 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: January 12, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Diabete Type 2
• Diabetes Mellitus, Type 2
• Inflammation

Intervention

Other:
• data collection
collection of data about bronchial and systemic inflammation, quality of life, lung function

Locations

Country	Name	City	State
Italy	Istituti Clinici Maugeri Pneumologia	Tradate	Lombardia

Sponsors (2)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA	Galmarini Hospital, Tradate

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

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