Glycaemic index dietary education for glucose abnormalities in cystic fibrosis

Not Applicable

Completed

• Conditions: Cystic fibrosis-related diabetes; Nutritional, Metabolic, Endocrine; Cystic fibrosis

• Registration Number: ISRCTN10838115
• Lead Sponsor: niversity of Bristol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-25
• Study Completion: 2020-05-31
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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

1. Pregnant/planning pregnancy
2. Understanding/command of English not of a sufficient standard to ensure informed consent and full participation in the research

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The feasibility of glycaemic index/glycaemic load dietary education (GLIDE) intervention in young people<br> with CF and abnormal blood glucose control, assessed through measurement of:<br> 1. Recruitment to the study: recorded as the number of eligible participants who consent to participate in the study by 18 months<br> 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)<br> 3. Acceptability of GLIDE intervention: assessed through qualitative interviews following the 12-week intervention period (approx. 14 weeks from baseline)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Glycaemic control using Continuous Glucose Monitoring (CGM) and HbA1c at baseline and at 12-week follow-up<br> 2. Energy and nutrient intake using a web-based 24-hour dietary recall system at baseline and at 12-week follow-up<br> 3. Body weight using clinic weighing scales and lung function using spirometry at baseline and at 12-week follow-up<br>