CompletedPhase 3ACTRN12615001029583

Does exenatide improve post prandial glycaemic control in young people with cystic fibrosis related diabetes or impaired glucose tolerance?

The use of exenatide, a GLP-1 agonist, in young people with cystic fibrosis related diabetes and impaired glucose tolerance in the management of post prandial glycaemia, gastric emptying and incretins.

Sponsor

Jennifer Couper

Enrollment

10 participants

Start Date

Mar 16, 2016

Study Type

Interventional

Conditions

Cystic Fibrosis with Impaired Glucose Tolerance

Summary

Aim to evaluate the effect of exenatide on postprandial glycaemia in patients with cystic fibrosis related diabetes (CFRD) and impaired glucose tolerance (IGT). CFRD has a detrimental impact on pulmonary function, mortality and prognosis after lung transplant, that is currently treated by intensive insulin regimen. GLP-1 is released in response to food ingestion and is known to stimulate insulin secretion, suppress glucagon secretion and slow gastric emptying. Exenatide is a GLP-1 (glucagon-like peptide 1) agonist that can be administered daily without significant risk of hypoglycaemia. It is anticipated that exenatide will normalise postprandial glycaemia. This is a double blinded crossover trial where participants will have 2 study days. On the first day they will receive the intervention or placebo, receiving the opposite on the second day. Once the intervention or placebo has been given, the participant will consume a pancake followed by assessment of glycaemia, incretin response and gastric emptying.

Eligibility

Sex: Both males and femalesMin Age: 10 YearssMax Age: 25 Yearss

Inclusion Criteria5

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 Criteria6

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

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Interventions

Double blind cross-over single dose study. The intervention is exenatide, 2.5 micrograms, subcutaneously administered 15 minutes prior to the commencement of a pancake meal. Exenatide is a cle

Double blind cross-over single dose study. The intervention is exenatide, 2.5 micrograms, subcutaneously administered 15 minutes prior to the commencement of a pancake meal. Exenatide is a clear fluid, identical to the placebo (0.9% normal saline). There will be 2 study days with at least 2 days between start times. The medication will be administered on the study day by the researcher. The pancake will be prepared and provided on the study day by the researcher.

Locations(1)

SA, Australia

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ACTRN12615001029583