Do blood glucose levels after meals relate to gut hormones and stomach emptying in young people with cystic fibrosis?

Not Applicable

Completed

• Conditions: Cystic Fibrosis; Cystic fibrosis related diabetes; Metabolic and Endocrine - Diabetes; Human Genetics and Inherited Disorders - Cystic fibrosis

• Registration Number: ACTRN12612000618853
• Lead Sponsor: Adelaide University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

16 subjects with cystic fibrosis (CF) with exocrine pancreatic insufficiency and taking pancreatic enzymes. CF related diabetes will be defined as those with diabetes detected on an oral glucose tolerance test (WHO definition); CF without diabetes will be defined as those with a normal glucose tolerance test in the previous 12 months.

16 healthy control subjects without clinically significant systemic disease, and BMI <95th centile will be recruited and will be matched for age to the CF subjects.

Exclusion Criteria

Exclusion criteria CF subjects: severe pulmonary disease (FEV1<30% predicted), significant liver disease (Child-Pugh score >6), previous gastrointestinal surgery (apart from uncomplicated appendicectomy), requirement for medications that could affect gastrointestinal motility (eg erythromycin, SSRIs), pregnancy or lactation

Exclusion criteria controls: previous gastrointestinal surgery (apart from uncomplicated appendicectomy), requirement for medications that could affect gastrointestinal motility (eg erythromycin, SSRIs), pregnancy or lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the relationship of postprandial glycaemia with gastric emptying and incretin response in young people with cystic fibrosis<br><br>Assessments:<br>Gastric Empyting:<br>13C labelled Na-octanoate (100mg) will be added to each pancake. Samples will be analysed for 13CO2 using an isotope ratio mass spectrometer. 13CO2 excretion rate will be used to calculate gastric emptying using a non-linear regression model as co -investigators have described.<br><br>Blood samples: Incretin hormones/insulin/glucagon/glucose<br>Blood glucose concentration will be measured immediately using a glucometer (Medisense Companion 2), and the remainder of the sample will be placed in EDTA tubes containing aprotinin on ice. Plasma will be separated and samples stored at -70 degrees C for subsequent analysis of plasma insulin, glucagon, GLP-1, and GIP using established assays at Royal Adelaide Hospital.[times = -15, -5, 15, 30, 45, 60, 90, 120, 150, 180, 240 min]

Secondary Outcome Measures

Name	Time	Method
Quantify the impact of pancreatic enzyme replacement on gastric emptying, incretin response and postprandial glycaemia in subjects with CF.<br><br>Tools:<br><br>Gastric Empyting:<br>13C labelled Na-octanoate (100mg) will be added to each pancake. Samples will be analysed for 13CO2 using an isotope ratio mass spectrometer. 13CO2 excretion rate will be used to calculate gastric emptying using a non-linear regression model as co -investigators have described.<br><br>Blood samples: Incretin hormones/insulin/glucagon/glucose.<br>Blood glucose concentration will be measured immediately using a glucometer (Medisense Companion 2), and the remainder of the sample will be placed in EDTA tubes containing aprotinin on ice. Plasma will be separated and samples stored at -70 degrees C for subsequent analysis of plasma insulin, glucagon, GLP-1, and GIP using established assays at Royal Adelaide Hospital.[times = -15, -5, 15, 30, 45, 60, 90, 120, 150, 180, 240 min]