Effect of Inhaled Steroids on Glucose Regulation in Asthma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00959348
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : August 14, 2009
Information provided by:
The University of Hong Kong

Brief Summary:
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 or disease

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 1394 participants
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
Study Start Date : August 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Asthma patients on inhaled corticosteroids
Select matched controls from the general population database of Cardiovascular Risk Factor Prevalence Study 2 (CRISPS2)

Primary Outcome Measures :
  1. To investigate the ICS effect on the risk of DM/IGT/insulin resistance [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To study the dose response relationship and effect modifying factors if risk is present [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Plasma, serum and DNA

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   35 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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).

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

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 identifier (NCT number): NCT00959348

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
Principal Investigator: Chung-man James Ho The University of Hong Kong

Responsible Party: Dr. HO Chung Man James, Clinical Assistant Professor, The University of Hong Kong Identifier: NCT00959348     History of Changes
Other Study ID Numbers: UW 07-291
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: August 14, 2009
Last Verified: August 2009

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

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