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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001029583
• Date of registration: 01/10/2015
• Prospective Registration: Yes
• Primary sponsor: Jennifer Couper
• Public title: Does exenatide improve post prandial glycaemic control in young people with cystic fibrosis related diabetes or impaired glucose tolerance?
• Scientific title: 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.
• Date of first enrolment: 16/03/2016
• Target sample size: 10
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001029583.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;
• Phase: Phase 3

Countries of recruitment

Australia

Contacts

• Name: Dr Myfanwy Geyer

• Name: Dr Myfanwy Geyer

Key inclusion & exclusion criteria

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

Age minimum: 10 Years
Age maximum: 25 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cystic Fibrosis Related Diabetes;Cystic Fibrosis with Impaired Glucose Tolerance;
Cystic Fibrosis Related Diabetes
Cystic Fibrosis with Impaired Glucose Tolerance

Metabolic and Endocrine - Diabetes

Human Genetics and Inherited Disorders - Cystic fibrosis

Intervention(s)

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.

Primary Outcome(s)

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(s)

Gastric half emptying time through measurement by 13C Na-octanoae breath test[ After intervention and eating pancake meal, 15 minutely for 2 hours then 30 minutely for 2 hours.]

Plasma concentration of glucagon-like peptide 1 (GLP-1)[Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.]

Plasma concentration of glucagon[Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.]

Plasma concentration of triglycerides[Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.]

Plasma concentration of insulin[Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.]

Plasma concentration of C-peptide[Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.]

Plasma concentration of free fatty acids[Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.]

Plasma concentration of glucose[Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.]

Serum Glucose dependent insulinotropic polypeptide (GIP) assay[Prior to administration of intervention, then after eating the pancake meal at timepoints (minutes) +15, +30, +45, +60, +90, +120, +150, +180 and +240.]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

The Channel 7 Children's Research Foundation of South Australia

Secondary Sponsor(s)

University of Adelaide

Women's and Children's Health Network

Ethics review

Status: Approved
Approval date:
Contact:

Women's and Children's Health Network Human Research Ethics Committee