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Effect of Inhaled Steroids on Glucose Regulation in Asthma Patients

This study has been completed.
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00959348
First received: August 9, 2009
Last updated: August 12, 2009
Last verified: August 2009
  Purpose

Inhaled steroid has been the cornerstone in the treatment of asthma, which carries a huge patient population worldwide including Hong Kong. In general, the safety of long-term use of inhaled steroid has been well documented. Yet, long-term users of such treatment carry increased risk of complications like cataract. In particular, the exact association of inhaled steroid use and development of diabetes mellitus is not known, despite a clear causal relationship between oral steroid use and diabetes. Therefore this epidemiology study (based on questionnaire and blood tests) aims to investigate the effect of inhaled corticosteroid on the risk of diabetes, impaired glucose tolerance and insulin resistance in adults with asthma. The impact of this study is expected to affect the current practice of long-term use of inhaled corticosteroid especially among patients with asthma.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Effect of Inhaled Corticosteroids on the Risk of Diabetes, Impaired Glucose Tolerance and Characteristics of Glucose Regulation in Adults With Asthma : a Population Based Matched Controlled Study

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • To investigate the ICS effect on the risk of DM/IGT/insulin resistance [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study the dose response relationship and effect modifying factors if risk is present [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma, serum and DNA


Enrollment: 1394
Study Start Date: August 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asthma
Asthma patients on inhaled corticosteroids
Control
Select matched controls from the general population database of Cardiovascular Risk Factor Prevalence Study 2 (CRISPS2)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Asthma patients will be recruited from asthma clinic in Queen Mary Hospital, Queen Elizabeth Hospital, Kowloon Hospital, Kwong Wah Hospital and select matched controls at 1:1 ratio from the general population database of Cardiovascular Risk Factor Prevalence Study 2 (CRISPS2).

Criteria

Inclusion Criteria:

  • Asthma patients who have follow-up in our asthma clinics; OR Eligible subjects belonging to 1996 population cohort, which represents the general population ie. same base population as the asthma patients
  • Current inhaled corticosteroid users

Exclusion Criteria:

  • On maintenance oral steroid
  • Oral steroid use within 180 days prior to study
  • IDDM
  • Known secondary causes for diabetes including pregnancy, cushing's syndrome and acromegaly
  • Inhaled corticosteroid use for < 6 months
  • Asthma exacerbation in recent 1 month, yet without need for systemic steroid use, as previous study has shown increased insulin resistance in subjects with unstable asthma, in relation to the acute stress during attack, which subsequently returned to normal after 1 month on disease stabilization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959348

Locations
Hong Kong
Kowloon Hospital
Hong Kong, Hong Kong
Kwong Wah Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Chung-man James Ho The University of Hong Kong
  More Information

No publications provided

Responsible Party: Dr. HO Chung Man James, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00959348     History of Changes
Other Study ID Numbers: UW 07-291
Study First Received: August 9, 2009
Last Updated: August 12, 2009
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Asthma
Diabetes
Impaired glucose tolerance
Insulin resistance

Additional relevant MeSH terms:
Asthma
Glucose Intolerance
Bronchial Diseases
Glucose Metabolism Disorders
Hyperglycemia
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Metabolic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014