Cystic fibrosis-related diabetes Nutritional, Metabolic, Endocrine Cystic fibrosis
Conditions
Interventions
This is a mixed-methods study to evaluate the feasibility of glycaemic index/glycaemic load dietary education (GLIDE) intervention in young people with cystic fibrosis and glucose abnormalities.
clinical status will be assessed via telephone using the modified criteria of Fuchs et al prior to Research Contact 1 to identify any exacerbations/steroid use. If any change in usual clinical status
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 12/08/2022: 1. Aged 11-35 years 2. CF diagnosis based on either genotype and/or phenotypic presentation 3. Established CFRD or at risk of developing CFRD as defined by: 3.1. HbA1c = 6.5% 3.2. Previously recorded abnormal oral glucose tolerance test (OGTT), defined as a 120-minute plasma venous sample =7.8mmol/l 3.3. Previous abnormal continuous glucose monitoring (CGM) result, defined as CGM time above 7.8 mmol/l =4.5% _____ Previous inclusion criteria: 1. Aged 11-30 years 2. CF diagnosis based on either genotype and/or phenotypic presentation 3. Established CFRD or at risk of developing CFRD as defined by: 3.1. HbA1c = 6.5% 3.2. Previously recorded abnormal oral glucose tolerance test (OGTT), defined as a 120-minute plasma venous sample =7.8mmol/l 3.3. Previous abnormal continuous glucose monitoring (CGM) result, defined as CGM time above 7.8 mmol/l =4.5%
Exclusion criteria
Exclusion criteria: 1. Pregnant/planning pregnancy 2. Understanding/command of English not of a sufficient standard to ensure informed consent and full participation in the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of glycaemic index/glycaemic load dietary education (GLIDE) intervention in young people with CF and abnormal blood glucose control, assessed through measurement of: 1. Recruitment to the study: recorded as the number of eligible participants who consent to participate in the study by 18 months 2. Attendance at research visits: recorded as the number of research visits attended at the end of the study period (approx. 14 weeks from baseline) 3. Acceptability of GLIDE intervention: assessed through qualitative interviews following the 12-week intervention period (approx. 14 weeks from baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Glycaemic control using Continuous Glucose Monitoring (CGM) and HbA1c at baseline and at 12-week follow-up 2. Energy and nutrient intake using a web-based 24-hour dietary recall system at baseline and at 12-week follow-up 3. Body weight using clinic weighing scales and lung function using spirometry at baseline and at 12-week follow-up | — |
Countries
England, United Kingdom
Outcome results
None listed