Does exenatide improve post prandial glycaemic control in young people with cystic fibrosis related diabetes or impaired glucose tolerance?
Phase 3
Completed
- Conditions
- Cystic Fibrosis Related DiabetesCystic Fibrosis with Impaired Glucose ToleranceMetabolic and Endocrine - DiabetesHuman Genetics and Inherited Disorders - Cystic fibrosis
- Registration Number
- ACTRN12615001029583
- Lead Sponsor
- Jennifer Couper
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Male or Female patients aged 10-25 years with cystic fibrosis with exocrine pancreatic insufficiency taking pancreatic enzymes.
WITH
Cystic Fibrosis Related Diabetes (CFRD) (2 hour glucose on routine OGTT >11.1 mmol/L),
OR CFRD without fasting hyperglycaemia,
OR Cystic Fibrosis with Impaired Glucose Tolerance (CF with IGT) (2 hour glucose >7.8mmol/L<11.1mmol/L)
Exclusion Criteria
Severe pulmonary disease (FEV1 <30% predicted)
Significant liver disease (Child-Pugh score >6)
Requirement for medications that could affect gastrointestinal motility (eg. erythromycin, SSRI)
Severe renal impairment
Previous stomach or small bowel surgery
Pregnancy or lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Post prandial glycaemia measured as peak glucose and area under the curve for blood glucose at 240 minutes.[4 hours after intervention or placebo]
- Secondary Outcome Measures
Name Time Method