The effect of low glucose load diet on glycaemic control in patients with cystic fibrosis

• Conditions: Cystic fibrosis; Metabolic and Endocrine - Other endocrine disorders; Human Genetics and Inherited Disorders - Cystic fibrosis

• Registration Number: ACTRN12616001159448
• Lead Sponsor: Academic Department of Adolescent Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence to a low GL diet in CF measured by 3 day food records, QOL. questionnaire (CFQ-R) and patient food acceptability questionnaire.[3 day food records will be reviewed at baseline, 1 month and 3 months.<br>QOL and patient food acceptability questionnaires will be performed at baseline and 3 months]

Secondary Outcome Measures

Name	Time	Method
Glycaemic control measured by 3 day glucometer or CGM readings, HbA1c and OGTT[3 day glucometer or CGM readings will be measured at baseline, 1 month, 3 months<br>HbA1c and OGTT will be performed at baseline and 3 months];Lung function as measured by FEV1 and FVC[Baseline, 1 month and 3 months];Nutrition status as measured by weight, height and BMI[Baseline, 1 month and 3 months]