The effect of the glucagon-like peptide-1 analogue, exenatide, on duodenal motility and flow events, and small intestinal transit in healthy humans and type 2 diabetes mellitus.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000428369

Enrollment

Registered

2008-08-26

Start date

2008-12-05

Completion date

2014-03-28

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

Glucagon-like peptide-1 (GLP-1) is a naturally occurring hormone in the human body that has the effect of stimulating insulin secretion and slowing stomach emptying, helping to limit the rise in blood glucose after a meal. Exenetide is a drug that mimics GLP-1, and has recently been approved in Australia for the treatment of diabetes. However, there is little information on how GLP-1 can affect the small intestine. The aim of this study is to see what effect exenatide has on the contractions and flow of contents inside the small intestine and how it affects glucose absorption. The findings will help us understand how sugar is absorbed in the small intestine in health and in people with diabetes, and whether the effects of exenatide on small intestinal function would benefit people with diabetes.

Interventions

Each subject will be studied on 2 occasions in a double-blind, randomised crossover design, separated by at least 3 days. On both days, subjects will receive an intraduodenal glucose infusion at a rate of 3 kcal/min from t = 0 to 60 min. On one day, an intravenous (IV) infusion of exenatide will be administered (50 ng/min between t = -30 to 0 min, then 25 ng/min between 0 and 240 min). On the other day, IV saline 0.9% will be administered between t = -30 and 240 min) .

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy subjects: 1. Body mass index (BMI) 19 - 25 kg/m2 Type 2 diabetic patients: 1. Body mass index (BMI) 19 - 35 kg/m2 2. Type 2 diabetes (World Health Organisation (WHO) criteria) managed by diet alone (i.e no oral hypoglycaemic drugs or insulin)

Exclusion criteria

History of gastrointestinal surgery (except appendicectomy) 1. Medication which may affect gastrointestinal motor function, specifically: opiates, anticholinergics, levodopa, calcium-channel antagonists, beta blockers, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, tegaserod, erythromycin 2. Other significant illness, including epilepsy, cardiovascular or respiratory disease 3. Pregnancy or lactation 4. Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes per day 5. Regular gastrointestinal symptoms (as assessed by a validated upper gastrointestinal symptom questionnaire) 6. Autonomic nerve damage (as assessed by standardised cardiovascular reflex tests)

Outcome results