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

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ClinicalTrials.gov Identifier: NCT04448262
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : June 29, 2020
Sponsor:
Collaborator:
Galmarini Hospital, Tradate
Information provided by (Responsible Party):
Istituti Clinici Scientifici Maugeri SpA

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.

Condition or disease Intervention/treatment
Asthma Diabete Type 2 Other: data collection

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bronchial Asthma and Diabetes: Impact on Bronchial Inflammation and Exercise Capacity
Actual Study Start Date : July 10, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
G1
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
Other: data collection
collection of data about bronchial and systemic inflammation, quality of life, lung function

G2
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
Other: data collection
collection of data about bronchial and systemic inflammation, quality of life, lung function

G3
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
Other: data collection
collection of data about bronchial and systemic inflammation, quality of life, lung function




Primary Outcome Measures :
  1. inflammatory cells [ Time Frame: baseline ]
    macrophages%,neutrophils%, eosinophils%, lymphocytes%


Secondary Outcome Measures :
  1. Expiratory muscles strength [ Time Frame: baseline ]
    Maximal inspiratory pressure -MIP, Maximal expiratory pressure -MEP

  2. Functional capacity of exercise [ Time Frame: baseline ]
    6 minutes walking test-6MWT

  3. Dyspnoea and muscular fatigue [ Time Frame: baseline ]
    Dyspnoea and muscle fatigue measured with Modified Borg Scale (0-10, where 0 is better)

  4. peripheral muscle strength [ Time Frame: baseline ]
    Five Sit to Stand Test-5STS

  5. Health related Quality of life [ Time Frame: baseline ]
    St. George Respiratory Questionnaire-SGRQ, scores range from 0 to 100, with higher scores indicating more limitations

  6. perceived Health state [ Time Frame: baseline ]
    Chronic Obstructive Pulmonary Disease Assessment test-CAT, Scores range from 0 to 40, with higher scores indicating worse health state



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448262


Contacts
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Contact: Dina Visca, MD,PhD +390331829298 ricerca.tradate@icsmaugeri.it
Contact: Elisabetta Zampogna, MSc 0331829503 elisabetta.zampogna@icsmaugeri.it

Locations
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Italy
Istituti Clinici Maugeri Pneumologia Recruiting
Tradate, Lombardia, Italy, 21049
Contact: Dina Visca    +390331829409    dina.visca@icsmaugeri.it   
Contact: Francesca Cherubino    +390331829599    francesca.cherubino@icsmaugeri.it   
Sub-Investigator: Antonio Spanevello, MD         
Sponsors and Collaborators
Istituti Clinici Scientifici Maugeri SpA
Galmarini Hospital, Tradate
Publications:
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Responsible Party: Istituti Clinici Scientifici Maugeri SpA
ClinicalTrials.gov Identifier: NCT04448262    
Other Study ID Numbers: 2290 CE
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituti Clinici Scientifici Maugeri SpA:
eosinophils, symptoms, lung
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases