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Trial registered on ANZCTR


Registration number
ACTRN12616001175460
Ethics application status
Approved
Date submitted
21/08/2016
Date registered
26/08/2016
Date last updated
26/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevalence of hypoglycaemia during extended oral glucose tolerance test in people with Cystic Fibrosis
Scientific title
Prevalence of hypoglycaemia and the role of incretins and glucagon during extended oral glucose tolerance test in people with Cystic Fibrosis
Secondary ID [1] 289677 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 299476 0
Condition category
Condition code
Metabolic and Endocrine 299456 299456 0 0
Other endocrine disorders
Human Genetics and Inherited Disorders 299695 299695 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
Participants will undergo an extended oral glucose tolerance test (OGTT) at their annual scheduled OGTT. This study will measure insulin and glucose at 30 minutes and 3 hours in addition to routine fasting, 1-hour and 2-hour measurements. Blood samples will also be collected at each of the 5 timepoints to measure additional hormones including glucagon, glucagon-like peptide-1 (GLP-1) and gastric inhibitory protein (GIP).
Intervention code [1] 295464 0
Not applicable
Comparator / control treatment
Controls will be pre-transplant, non-liver disease patients at the RPA CF clinic who have normal glucose tolerance, have not had hypoglycaemia on previous OGTT or reported symptoms suggestive of hypoglycaemia.
Control group
Active

Outcomes
Primary outcome [1] 299098 0
Prevalence of hypoglycaemia (glucose less than or equal to 3.9mmol/L) during extended OGTT
Timepoint [1] 299098 0
Fasting, 30min, 60min, 120min, 180min following 75g oral glucose load
Secondary outcome [1] 326346 0
Trends in glucose during OGTT assessed by plasma glucose levels
Timepoint [1] 326346 0
Fasting, 30min, 60min, 120min, 180min following 75g oral glucose load
Secondary outcome [2] 327024 0
Trends in insulin during OGTT assessed by plasma insulin levels
Timepoint [2] 327024 0
Fasting, 30min, 60min, 120min, 180min following 75g oral glucose load
Secondary outcome [3] 327025 0
Trends in glucagon during OGTT assessed by plasma glucagon levels
Timepoint [3] 327025 0
Fasting, 30min, 60min, 120min, 180min following 75g oral glucose load
Secondary outcome [4] 327026 0
Trends in GLP-1 during OGTT assessed by plasma GLP-1 levels
Timepoint [4] 327026 0
Fasting, 30min, 60min, 120min, 180min following 75g oral glucose load
Secondary outcome [5] 327027 0
Trends in GIP during OGTT assessed by plasma GIP levels
Timepoint [5] 327027 0
Fasting, 30min, 60min, 120min, 180min following 75g oral glucose load

Eligibility
Key inclusion criteria
Group 1: Patients at the RPA CF clinic who have experienced hypoglycaemia on a previous OGTT
Group 2: Patients at the RPA CF clinic who have reported symptoms suggestive of hypoglycaemia to a clinic health professional
Group 3: Pre-transplant, non-liver disease patients at the RPA CF clinic who have normal glucose tolerance in the absence of previous hypoglycaemia on OGTT and previously reported hypoglycaemia.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnant or lactating
Patients who have had a lung transplant
Patients who are identified to have cystic fibrosis related diabetes (CFRD), insulin and oral hypoglycaemic medications
People with significant cognitive impairment, mental illness, or involved in an illegal activity who are unfit for participation

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Differences in demographic, clinical and biochemical parameters between groups will be analysed using appropriate statistical software. As this is a pilot/observational study, statistical estimation of sample size has not been completed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/05/2016
Date of last participant enrolment
Anticipated
31/12/2016
Actual
Date of last data collection
Anticipated
30/06/2017
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6318 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 13853 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 294180 0
Hospital
Name [1] 294180 0
Royal Prince Alfred Hospital
Country [1] 294180 0
Australia
Primary sponsor type
Hospital
Name
Academic Department of Adolescent Medicine
Address
Academic Department of Adolescent Medicine
Children's Hospital at Westmead
Cnr Hawkesbury Road and Hainsworth Street, Westmead
Locked Bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 293196 0
None
Name [1] 293196 0
Address [1] 293196 0
Country [1] 293196 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295583 0
Royal Prince Alfred Hospital
Ethics committee address [1] 295583 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 295583 0
Australia
Date submitted for ethics approval [1] 295583 0
Approval date [1] 295583 0
27/11/2015
Ethics approval number [1] 295583 0
HREC/15/RPAH/487

Summary
Brief summary
This study aims to identify the prevalence of hypoglycaemia during extended OGTTs and associations with biochemical parameters relevant to glucose metabolism. In particular, this study will explore the role of glucagon and the incretins GLP-1 and GIP in reactive hypoglycaemia during OGTTs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67414 0
Prof Kate Steinbeck
Address 67414 0
Academic Department of Adolescent Medicine
Children's Hospital at Westmead
Cnr Hawkesbury Road and Hainsworth Street, Westmead
Locked Bag 4001
NSW 2145
Country 67414 0
Australia
Phone 67414 0
+61 2 9845 2517
Fax 67414 0
Email 67414 0
[email protected]
Contact person for public queries
Name 67415 0
Ms Natasha Armaghanian
Address 67415 0
Academic Department of Adolescent Medicine
Children's Hospital at Westmead
Cnr Hawkesbury Road and Hainsworth Street, Westmead
Locked Bag 4001
NSW 2145
Country 67415 0
Australia
Phone 67415 0
+61 2 9845 2517
Fax 67415 0
Email 67415 0
[email protected]
Contact person for scientific queries
Name 67416 0
Ms Natasha Armaghanian
Address 67416 0
Academic Department of Adolescent Medicine
Children's Hospital at Westmead
Cnr Hawkesbury Road and Hainsworth Street, Westmead
Locked Bag 4001
NSW 2145
Country 67416 0
Australia
Phone 67416 0
+61 2 9845 2517
Fax 67416 0
Email 67416 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
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