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

NCT04448262 | Terminated

• 1 other identifier: 2290 CE
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Diabete Type 2

Keywords

eosinophils, symptoms, lung

Outcome Measures

Primary Outcomes (1)

• inflammatory cells

  macrophages%,neutrophils%, eosinophils%, lymphocytes%

  baseline

Secondary Outcomes (6)

• Expiratory muscles strength

  baseline

• Functional capacity of exercise

  baseline

• Dyspnoea and muscular fatigue

  baseline

• peripheral muscle strength

  baseline

• Health related Quality of life

  baseline

Study Arms (3)

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

Other: data collection

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

Other: data collection

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

Other: data collection

Interventions

data collection OTHER

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

G1 Asthma; G2 Diabetes; G3 Asthma plus diabetes

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Bronchial asthma and/or diabetes with scarce clinical control.
• Diagnosis of cognitive impairment
• Not able to carry out study procedures

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Galmarini Hospital, Tradate: collaborator

Study Sites (1)

Istituti Clinici Maugeri Pneumologia

Tradate, Lombardy, 21049, Italy

Location

Related Publications (4)

• 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.

  PMID: 507532 BACKGROUND

• 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.

  PMID: 30312663 BACKGROUND

• 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.

  PMID: 27103388 BACKGROUND

• 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.

  PMID: 29310905 BACKGROUND

MeSH Terms

Conditions

Asthma; Diabetes Mellitus, Type 2

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Antonio Spanevello, Prof

  ICS Maugeri

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: June 25, 2020
• Study Start: July 10, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 12, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-01

Locations

IT (1)