Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000378022
Ethics application status
Approved
Date submitted
10/05/2010
Date registered
11/05/2010
Date last updated
14/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of metformin on lung function in diabetic or prediabetic individuals with respiratory disease
Scientific title
The effect of oral metformin on spirometry, exercise capacity and quality of life in adults with chronic obstructive pulmonary disease (COPD) and either diet-controlled type 2 diabetes mellitus or impaired glucose tolerance.
Secondary ID [1] 251712 0
None
Universal Trial Number (UTN)
U1111-1114-9527
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 257316 0
Type 2 diabetes mellitus 257317 0
Impaired glucose tolerance 257318 0
Insulin resistance 257319 0
Condition category
Condition code
Respiratory 257460 257460 0 0
Chronic obstructive pulmonary disease
Metabolic and Endocrine 257461 257461 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral metformin 850mg twice daily for 6 months.
Intervention code [1] 256439 0
Treatment: Drugs
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258380 0
Change in forced expiratory volume in first second (FEV1), measured using spirometer
Timepoint [1] 258380 0
Baseline, 6 weeks, 12 weeks, 18 weeks, 24 weeks
Secondary outcome [1] 264114 0
Change in incremental shuttle walk distance
Timepoint [1] 264114 0
Baseline and 24 weeks
Secondary outcome [2] 264115 0
change in respiratory quality of life score (St George Respiratory questionnaire)
Timepoint [2] 264115 0
Baseline and 24 weeks

Eligibility
Key inclusion criteria
* Obese (body mass index > 30)
* Central pattern of obesity (elevated waist circumference)
* Impaired glucose tolerance or diet-controlled type 2 diabetes mellitus (previous diagnosis, or evidence of blood tests meeting American Diabetes Association 2010 criteria)
* Post-bronchodilator spirometry that is consistent with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2+ COPD
* Symptomatic: Medical Research Council dyspnoea score of 2 or higher
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently taking oral hypoglycaemic agent or insulin
2. Active respiratory disease other than obstructive airways disease
3. Exacerbation of airways disease requiring change in treatment within the preceding 6 weeks
4. Participation in pulmonary rehabilitation programme within the past 6 weeks
5. Currently prescribed long term oral corticosteroids
6. Renal impairment (estimated glomerular filtration rate < 45 mL/min)
7. Cirrhosis, impaired synthetic liver function, or liver failure
8. Chronic respiratory failure
9. Congestive heart failure
10. Current or recent habitual heavy alcohol intake
11. Current use of antiretroviral medication
12. Pregnancy
13. History of lactic acidosis
14. Allergy to metformin
15. Unable to comply with the study procedures or protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential subjects are identified from outpatient records.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2011
Actual
9/06/2011
Date of last participant enrolment
Anticipated
Actual
7/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
17
Recruitment outside Australia
Country [1] 2619 0
New Zealand
State/province [1] 2619 0

Funding & Sponsors
Funding source category [1] 256930 0
Charities/Societies/Foundations
Name [1] 256930 0
Greenlane Research and Educational Fund
Country [1] 256930 0
New Zealand
Primary sponsor type
Individual
Name
Dr Paul Sexton
Address
Department of Medicine, Building 599, Faculty of Medical & Health Sciences, University of Auckland
PO Box 92019
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 256196 0
Individual
Name [1] 256196 0
Prof John Kolbe
Address [1] 256196 0
Department of Medicine, Building 599, Faculty of MEdical & Health Sciences, University of Auckland
PO Box 92019
Grafton
Auckland 1023
Country [1] 256196 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258934 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 258934 0
Ethics committee country [1] 258934 0
New Zealand
Date submitted for ethics approval [1] 258934 0
01/06/2010
Approval date [1] 258934 0
14/09/2010
Ethics approval number [1] 258934 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31137 0
Dr Paul Sexton
Address 31137 0
Department of Medicine, Faculty of Medical & Health Sciences, Building 599, University of Auckland PO Box 92019 Grafton Auckland 1023
Country 31137 0
New Zealand
Phone 31137 0
+64-9-9237290
Fax 31137 0
Email 31137 0
p.sexton@auckland.ac.nz
Contact person for public queries
Name 14384 0
Dr Paul Sexton
Address 14384 0
Department of Medicine, Faculty of Medical & Health Sciences, Building 599, University of Auckland
PO Box 92019
Grafton
Auckland 1023
Country 14384 0
New Zealand
Phone 14384 0
+64-9-9237290
Fax 14384 0
Email 14384 0
p.sexton@auckland.ac.nz
Contact person for scientific queries
Name 5312 0
Dr Paul Sexton
Address 5312 0
Department of Medicine, Faculty of Medical & Health Sciences, Building 599, University of Auckland
PO Box 92019
Grafton
Auckland 1023
Country 5312 0
New Zealand
Phone 5312 0
+64-9-9237290
Fax 5312 0
Email 5312 0
p.sexton@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.