None listed
Conditions
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.
Interventions
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
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.
Sponsors
Academic Department of Adolescent Medicine
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed