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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04448262
Enrollment
39
Registered
2020-06-25
Start date
2019-07-10
Completion date
2024-01-12
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Diabete Type 2

Keywords

eosinophils, symptoms, lung

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.

Interventions

OTHERdata collection

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

Sponsors

Galmarini Hospital, Tradate
CollaboratorUNKNOWN
Istituti Clinici Scientifici Maugeri SpA
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
inflammatory cellsbaselinemacrophages%,neutrophils%, eosinophils%, lymphocytes%

Secondary

MeasureTime frameDescription
Functional capacity of exercisebaseline6 minutes walking test-6MWT
Dyspnoea and muscular fatiguebaselineDyspnoea and muscle fatigue measured with Modified Borg Scale (0-10, where 0 is better)
Expiratory muscles strengthbaselineMaximal inspiratory pressure -MIP, Maximal expiratory pressure -MEP
Health related Quality of lifebaselineSt. George Respiratory Questionnaire-SGRQ, scores range from 0 to 100, with higher scores indicating more limitations
perceived Health statebaselineChronic Obstructive Pulmonary Disease Assessment test-CAT, Scores range from 0 to 40, with higher scores indicating worse health state
peripheral muscle strengthbaselineFive Sit to Stand Test-5STS

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026