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Glycaemic Index Dietary Education for glucose abnormalities in Cystic Fibrosis

Details

Therapeutic category
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Nutritional-GI

Trial status

Open to recruitment

Participating Centres
Phase
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Not Applicable

Full title

GLIDE: Glycaemic Index Dietary Education for glucose abnormalities in cystic fibrosis

Few people with Cystic Fibrosis have normal blood glucose control and these glucose abnormalities eventually progress to cystic fibrosis-related diabetes (CFRD), the most common complication of Cystic Fibrosis. People with Cystic Fibrosis are encouraged to consume a high calorie diet to maintain weight. This typically means eating food and drinks that are often high in fat and/or sugar. For people with Cystic Fibrosis who also need to control their blood glucose levels, high sugar intake can make this difficult. There is limited evidence to guide dietary therapy for blood glucose abnormalities in Cystic Fibrosis. Manipulating the glycaemic index (GI) and glycaemic load (GL) of what is consumed may be a possible area for intervention to improve blood glucose control without compromising energy intake. This study will explore the feasibility of delivering glycaemic index/glycaemic load dietary education (GLIDE) in a sample of 20 young people with CF and abnormal blood glucose control. GLIDE intervention will be implemented by participants for 12 weeks. Dietary intake and glycaemic control will be measured at baseline and at 12 week follow-up using an on-line dietary recording tool and continuous glucose monitoring, respectively. The primary objective of this study is to investigate the feasibility of GLIDE intervention in young people with CF and abnormal blood glucose control. Secondary objectives include measuring glycaemic control, energy and nutrient intake, body weight and lung function before GLIDE intervention and at 12-week follow-up.

Trial Reference Number

107989

Trial type

Non-medication

Length of participation
the length of time a participant will take part in a trial, from the first to the last appointment

4 months

Intervention
the name of the treatment or therapy being researched

Dietary manipulation

Recruitment target
the number of participants who need to be recruited for the trial in the UK

20

Last edited date

12 April 2019

CF sponsor

University of Bristol

CF sponsor type

Academic

Who can take part?

Top inclusion criteria
  • Aged 11-30 years
  • Established CFRD or at risk of developing CFRD as defined by:HbA1c ≥ 6.5%.
  • Previously recorded abnormal oral glucose tolerance test (OGTT), defined as a 120-minute plasma venous sample ≥7.8mmol/l,
  • Previous abnormal continuous glucose monitoring (CGM) result, defined as CGM time above 7.8 mmol/l ≥4.5%
Top exclusion criteria
  • Pregnant/planning pregnancy
  • Understanding/command of English not of a sufficient standard to ensure informed consent and full participation in the research

CF centres running this trial

Recruiting

Heart of England NHS Foundation Trust

Address

Birmingham Heartlands Hospital Bordesley Green East Birmingham West Midlands B9 5SS

Recruitment starts

September 2018

Recruitment ends

December 2019

Contact

Barrett, Joanne

Get in touch

Recruiting

Royal Devon and Exeter Hospital (Wonford)

Address

Royal Devon and Exeter Hospital Barrack Road Exeter Devon EX2 5DW

Recruitment ends

December 2019

Contact

Moudiotis, Christopher

Get in touch

Recruiting

University Hospitals Bristol NHS Foundation Trust

Address

Marlborough Street, Bristol, Avon BS1 3NU

Recruitment starts

September 2018

Recruitment ends

September 2019

Contact

Birch, Laura

Get in touch