RecruitingPhase 2ACTRN12612001035819

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


Sponsor

Mahesh Umapathysivam

Enrollment

10 participants

Start Date

Jun 19, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 35 Yearss

Inclusion Criteria2

  • Healthy
  • Normal gastric functioning

Exclusion Criteria14

  • 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.

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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

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.


Locations(1)

Australia

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