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Trial registered on ANZCTR


Registration number
ACTRN12616001159448p
Ethics application status
Not yet submitted
Date submitted
22/08/2016
Date registered
25/08/2016
Date last updated
25/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of low glucose load diet on glycaemic control in patients with cystic fibrosis
Scientific title
The effect of low glucose load diet on glycaemic control in patients with cystic fibrosis
Secondary ID [1] 289804 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 299715 0
Condition category
Condition code
Metabolic and Endocrine 299651 299651 0 0
Other endocrine disorders
Human Genetics and Inherited Disorders 299817 299817 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description: This study is a prospective, single arm pilot study. Patients with impaired glucose tolerance at the Royal Prince Alfred (RPA) Cystic Fibrosis (CF) Clinic will be eligible to participate in this study. Baseline measures relating to anthropometric measures, lung function, inflammatory status, quality of life (QOL) usual dietary intake via 3 day food record, oral glucose tolerance test (OGTT) and blood glucose levels (BGLs) via continuous glucose monitoring (CGM) or glucometer will be measured. Dietary education about low glucose load (GL) dietary modification will then be provided to the patient.

There will be a one month follow up to review anthropometry, lung function, dietary intake, BGLs and food satisfaction survey. A three month follow up will review anthropometry, lung function, dietary intake, BGLs, QOL, inflammatory markers and food acceptability survey.

Dietary prescription: Participants will be prescribed a diet based on current recommendations for CF energy and protein requirements. Education will be provided at the RPA CF clinic by the clinic dietitian. The baseline food record will be used to guide education of the participant about a low GL diet. Sample meal plans will be provided demonstrating substitution of low GI dietary products and recommended meal and snack pattern, lists of low GI products will be provided and education about the ‘GI tick’ for recognition of low GI products on food labels..

Measurement of subject compliance: This pilot study aims to assess feasibility of patient compliance with low GL dietary recommendation in this patient group. Compliance will be assessed based on calculation of glycaemic index of diet based on 3 day food record.
Intervention code [1] 295622 0
Lifestyle
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299294 0
Adherence to a low GL diet in CF measured by 3 day food records, QOL. questionnaire (CFQ-R) and patient food acceptability questionnaire.
Timepoint [1] 299294 0
3 day food records will be reviewed at baseline, 1 month and 3 months.
QOL and patient food acceptability questionnaires will be performed at baseline and 3 months
Secondary outcome [1] 326770 0
Glycaemic control measured by 3 day glucometer or CGM readings, HbA1c and OGTT
Timepoint [1] 326770 0
3 day glucometer or CGM readings will be measured at baseline, 1 month, 3 months
HbA1c and OGTT will be performed at baseline and 3 months
Secondary outcome [2] 326771 0
Lung function as measured by FEV1 and FVC
Timepoint [2] 326771 0
Baseline, 1 month and 3 months
Secondary outcome [3] 327032 0
Nutrition status as measured by weight, height and BMI
Timepoint [3] 327032 0
Baseline, 1 month and 3 months

Eligibility
Key inclusion criteria
Patients with CF attending the RPA CF clinic with OGTT results within the previous 3 months of impaired glucose tolerance (IGT) i.e. 2-hour glucose of 7.8-11.1mmol/L.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants belonging to any of the following criteria will be excluded from the study:
Women who are pregnant or planning a pregnancy
Patients who have had a lung transplant because of prednisone effect
Patients who are identified to have cystic fibrosis related diabetes (CFRD), insulin and oral hypoglycaemic medications
Patients who have had a pulmonary exacerbation within one month of recruitment according to FUCHS criteria
Patients requiring nutrition support via nasogastric tube or gastrostomy
People who do not have the level of English required to complete QOL questionnaires
People with significant cognitive impairment, mental illness, or involved in an illegal activity who are unfit for participation
Patients who are on >7.5mg daily doses of prednisone
Patients with gastrointestinal dysfunction including DIOS and gastroparesis.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6488 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 14051 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 294311 0
Hospital
Name [1] 294311 0
Royal Prince Alfred Hospital
Country [1] 294311 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
Locked Bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 293150 0
None
Name [1] 293150 0
Address [1] 293150 0
Country [1] 293150 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 295738 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 295738 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 295738 0
Australia
Date submitted for ethics approval [1] 295738 0
30/08/2016
Approval date [1] 295738 0
Ethics approval number [1] 295738 0

Summary
Brief summary
Concentrated carbohydrate loads are often used in CF to help meet increased energy requirements and could have a role in the poor glycaemic control observed in CF. The aim of this project is therefore to establish the feasibility of implementing a low glycaemic load, high calorie dietary management plan for patients with CF and impaired glycaemic status (IGT). A secondary aim is to assess the effect of a low GL diet on clinical outcomes of glycaemic control, lung function and weight.

Patients with IGT at the RPA CF clinic will be eligible to participate in this study. Weight, glycaemic control, lung function, diet history and quality of life will be measured at baseline and also at 3 months, following dietary intervention of a low GL diet.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67870 0
Prof Kate Steinbeck
Address 67870 0
Academic Department of Adolescent Medicine
Children's Hospital at Westmead
Cnr Hawkesbury Road and Hainsworth Street
Locked Bag 4001
Westmead NSW 2145
Country 67870 0
Australia
Phone 67870 0
+61 2 9845 2517
Fax 67870 0
Email 67870 0
[email protected]
Contact person for public queries
Name 67871 0
Ms Natasha Armaghanian
Address 67871 0
Academic Department of Adolescent Medicine
Children's Hospital at Westmead
Cnr Hawkesbury Road and Hainsworth Street
Locked Bag 4001
Westmead NSW 2145
Country 67871 0
Australia
Phone 67871 0
+61 2 9845 2517
Fax 67871 0
Email 67871 0
[email protected]
Contact person for scientific queries
Name 67872 0
Ms Natasha Armaghanian
Address 67872 0
Academic Department of Adolescent Medicine
Children's Hospital at Westmead
Cnr Hawkesbury Road and Hainsworth Street
Locked Bag 4001
Westmead NSW 2145
Country 67872 0
Australia
Phone 67872 0
+61 2 9845 2517
Fax 67872 0
Email 67872 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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