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

NCT ID: NCT04448262

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-10

Study Completion Date

2024-01-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Diabete Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

data collection

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Galmarini Hospital, Tradate

UNKNOWN

Sponsor Role collaborator

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antonio Spanevello, Prof

Role: STUDY_DIRECTOR

ICS Maugeri

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istituti Clinici Maugeri Pneumologia

Tradate, Lombardy, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 507532 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30312663 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27103388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29310905 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2290 CE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bronchial Asthma & Its Exacerbation
NCT06331897 NOT_YET_RECRUITING