The Effect of Prolonged Glucagon-like Peptide 1 Infusion on Gastric Emptying in Healthy Volunteers

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001035819

Enrollment

Registered

2012-09-26

Start date

2012-06-19

Completion date

Unknown

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

The study aims to identify whether there is reduction in the effect of GLP-1 on gastric emptying with prolonged infusion of GLP-1. Hypothesis The GLP-1's effect of slowing gastric emptying will be reduced over time.

Interventions

Arm 1: intermittent GLP-1 infusion (0.8 pmol/kg/min over 2x4.5 hours separated by 19 hours) Arm 2: Acute GLP-1 infusion (0.8 pmol/kg/min over 4.5 hours)Arm 3: prolonged GLP-1 infusion(0.8 pmol/kg/min over 24 hours) Treatment order is randomised with a washout period of at least 3 days.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

1.Healthy 2.Normal gastric functioning

Exclusion criteria

- Inability to give informed consent, - Radiation exposure for research purposes in the past 12 months, - The ARPANSA guidelines published by the Australian Government entitled Code of Practice Exposure of Humans to Ionizing Radiation for Research Purposes States that the dose constraints for a research participant is 5mSv per year and 10mSv for a 5 year period. - History of diabetes, - HbA1c >6.0, - Taking medication that are known to effect gastrointestinal motility, - Taking medication effecting blood glucose, - Creatinine Clearance <100 ml/min (men), 90 ml/min (women) - Pregnancy, - Ferritin level < 20microg/L - Previous surgery on the small intestine, - Smoking >10 cigarettes per day - Alcohol >20g per day - Because of concerns of cumulative life time exposure to radiation, we will directly screen all volunteers as to their previous radiation exposure, and will exclude any volunteer who has received 3 or more examinations using a computerized tomogram and/or 10 or more examinations using standard x-rays.

Outcome results