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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001029583

Enrollment

Registered

2015-10-01

Start date

2016-03-16

Completion date

2017-02-16

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

10 Years to 25 Years

Healthy volunteers

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

Outcome results