Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000064606
Ethics application status
Approved
Date submitted
10/10/2013
Date registered
21/01/2014
Date last updated
19/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oral glucose tolerance testing in Cystic Fibrosis
Scientific title
An observational study of oral glucose tolerance testing results in subjects with Cystic Fibrosis.
Secondary ID [1] 283386 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 290285 0
Diabetes 290306 0
Condition category
Condition code
Respiratory 290675 290675 0 0
Other respiratory disorders / diseases
Metabolic and Endocrine 290676 290676 0 0
Diabetes
Human Genetics and Inherited Disorders 290697 290697 0 0
Cystic fibrosis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Oral glucose tolerance testing - performed following an overnight fast of at least 8 hours. Blood sampled through a venous puncture for the blood glucose, insulin and peptide measurements at 0, 30, 60 and 120 minutes following the oral administration of a 75g glucose load.
Lung function - spirometry performed according to the ATS guidelines.
Participants are assessed at baseline and 2-3 years later.
Intervention code [1] 288112 0
Not applicable
Comparator / control treatment
N/A - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290694 0
Document the prevalence and incidence of impaired glucose tolerance and diabetes in subjects with Cystic Fibrosis at age of 18-21 years.
OGTT was measured at baseline and at a subsequent time period (approximately 2-3 years).
Timepoint [1] 290694 0
Baseline and at a subsequent time period (approximately 2-3 years).
Secondary outcome [1] 305050 0
Document the trend of blood glucose levels in subjects with Cystic Fibrosis
Timepoint [1] 305050 0
Baseline to follow-up/subsequent review (approximately 2-3 years).
Secondary outcome [2] 305051 0
Document the relationship of the results of the OGTT with lung function.
OGTT was performed and spirometry performed according to the ATS guidelines.
Timepoint [2] 305051 0
Baseline
Secondary outcome [3] 305052 0
Document trend of lung function in association with trend of glucose intolerance.
OGTT was performed and spirometry performed according to the ATS guidelines. The results at baseline were compared with the results 2-3 years later.
Timepoint [3] 305052 0
Baseline to follow-up/subsequent review (approximately 2-3 years).

Eligibility
Key inclusion criteria
1. Diagnosis of Cystic Fibrosis
2. At least one OGTT and lung function testing - these tests were performed at any time in the past.
Minimum age
17 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2014
Actual
1/01/2014
Date of last participant enrolment
Anticipated
31/12/2014
Actual
1/03/2015
Date of last data collection
Anticipated
Actual
1/10/2017
Sample size
Target
100
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1584 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 7420 0
2120 - Pennant Hills
Recruitment postcode(s) [2] 7421 0
2121 - Epping
Recruitment postcode(s) [3] 7422 0
2123 - Parramatta
Recruitment postcode(s) [4] 7423 0
2124 - Parramatta
Recruitment postcode(s) [5] 7424 0
2125 - West Pennant Hills
Recruitment postcode(s) [6] 7425 0
2126 - Cherrybrook
Recruitment postcode(s) [7] 7426 0
2122 - Eastwood
Recruitment postcode(s) [8] 7427 0
2127 - Homebush Bay
Recruitment postcode(s) [9] 7428 0
2128 - Silverwater
Recruitment postcode(s) [10] 7429 0
2129 - Sydney Markets
Recruitment postcode(s) [11] 7430 0
2130 - Summer Hill
Recruitment postcode(s) [12] 7431 0
2131 - Ashfield
Recruitment postcode(s) [13] 7432 0
2132 - Croydon
Recruitment postcode(s) [14] 7433 0
2133 - Croydon Park
Recruitment postcode(s) [15] 7434 0
2134 - Burwood
Recruitment postcode(s) [16] 7435 0
2135 - Strathfield
Recruitment postcode(s) [17] 7436 0
2136 - Enfield
Recruitment postcode(s) [18] 7437 0
2137 - Cabarita
Recruitment postcode(s) [19] 7438 0
2138 - Concord West
Recruitment postcode(s) [20] 7439 0
2140 - Homebush
Recruitment postcode(s) [21] 7440 0
2141 - Lidcombe
Recruitment postcode(s) [22] 7441 0
2142 - Granville
Recruitment postcode(s) [23] 7442 0
2143 - Regents Park
Recruitment postcode(s) [24] 7443 0
2144 - Auburn
Recruitment postcode(s) [25] 7444 0
2145 - Westmead
Recruitment postcode(s) [26] 7445 0
2146 - Toongabbie
Recruitment postcode(s) [27] 7446 0
2147 - Seven Hills
Recruitment postcode(s) [28] 7447 0
2148 - Blacktown
Recruitment postcode(s) [29] 7448 0
2150 - Harris Park
Recruitment postcode(s) [30] 7449 0
2151 - North Parramatta
Recruitment postcode(s) [31] 7450 0
2153 - Baulkham Hills
Recruitment postcode(s) [32] 7451 0
2154 - Castle Hill
Recruitment postcode(s) [33] 7452 0
2156 - Glenhaven
Recruitment postcode(s) [34] 7453 0
2157 - Glenorie
Recruitment postcode(s) [35] 7454 0
2158 - Dural
Recruitment postcode(s) [36] 7455 0
2159 - Arcadia
Recruitment postcode(s) [37] 7456 0
2160 - Merrylands
Recruitment postcode(s) [38] 7457 0
2161 - Guildford
Recruitment postcode(s) [39] 7458 0
2162 - Sefton
Recruitment postcode(s) [40] 7459 0
2163 - Villawood
Recruitment postcode(s) [41] 7460 0
2164 - Smithfield
Recruitment postcode(s) [42] 7461 0
2165 - Fairfield
Recruitment postcode(s) [43] 7462 0
2166 - Cabramatta
Recruitment postcode(s) [44] 7463 0
2167 - Glenfield

Funding & Sponsors
Funding source category [1] 288111 0
Hospital
Name [1] 288111 0
Westmead Hospital
Country [1] 288111 0
Australia
Primary sponsor type
Individual
Name
Dr Odette Erskine
Address
Department of Respiratory and Sleep Medicine Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 286831 0
Individual
Name [1] 286831 0
Associate Professor Peter Middleton
Address [1] 286831 0
Department of Respiratory and Sleep Medicine Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country [1] 286831 0
Australia
Other collaborator category [1] 277648 0
Individual
Name [1] 277648 0
Dr Isabelle Bosi
Address [1] 277648 0
Department of Respiratory and Sleep Medicine Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country [1] 277648 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290033 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 290033 0
Research Office, Room 1072, Level 1, Education Block Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Ethics committee country [1] 290033 0
Australia
Date submitted for ethics approval [1] 290033 0
Approval date [1] 290033 0
16/12/2013
Ethics approval number [1] 290033 0
HREC2013/12/6.7(3887)QA

Summary
Brief summary
Assessment of the prevalence and incidence of glucose intolerance and diabetes in subjects with Cystic Fibrosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43594 0
Dr Odette Erskine
Address 43594 0
Department of Respiratory and Sleep Medicine
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country 43594 0
Australia
Phone 43594 0
+61 2 8890 6797
Fax 43594 0
Email 43594 0
[email protected]
Contact person for public queries
Name 43595 0
A/Prof Peter Middleton
Address 43595 0
Department of Respiratory and Sleep Medicine
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country 43595 0
Australia
Phone 43595 0
+61 2 8890 6797
Fax 43595 0
Email 43595 0
[email protected]
Contact person for scientific queries
Name 43596 0
A/Prof Peter Middleton
Address 43596 0
Department of Respiratory and Sleep Medicine
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country 43596 0
Australia
Phone 43596 0
+61 2 8890 6797
Fax 43596 0
Email 43596 0
[email protected]

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.