Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001035819
Ethics application status
Approved
Date submitted
23/07/2012
Date registered
26/09/2012
Date last updated
26/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Prolonged Glucagon-like Peptide 1 Infusion on Gastric Emptying in Healthy Volunteers
Scientific title
The Effect of Prolonged Glucagon-like Peptide 1 Infusion on Gastric Emptying in Healthy Volunteers
Secondary ID [1] 280900 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperglycaemia 286978 0
Diabetes 287339 0
Critical Illness Induced Hyperglycaemia 287340 0
Condition category
Condition code
Metabolic and Endocrine 287313 287313 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 285330 0
Treatment: Drugs
Comparator / control treatment
placebo (normal saline IV at 4.5 hours) Treatment order is randomised with a washout period of at least 3 days
Control group
Dose comparison

Outcomes
Primary outcome [1] 287590 0
Scintigraphic Measurement of Gastric Emptying
Timepoint [1] 287590 0
0,5,15,30,45,60,90,120,150,180,210,240 mins
Secondary outcome [1] 298475 0
Blood glucose analysis
Timepoint [1] 298475 0
-30, 0, 30, 60, 90, 120, 180, 300, 420, 480, 600, 660, 780, 900, 1020, 1140, 1260, 1380, 1410, 1440(24hrs), 1470, 1500, 1530, 1560, 1620 and 1680 min
Secondary outcome [2] 298476 0
Glucagon - blood analysis
Timepoint [2] 298476 0
-30, 0, 30, 60, 120, 180, 420, 480, 660, 900, 1140, 1410 1440, 1470, 1500, 1530, 1560, 1620 and 1680 min
Secondary outcome [3] 298477 0
GLP-1 - blood analysis
Timepoint [3] 298477 0
-30, 0, 30, 60, 120, 180, 420, 480, 660, 900, 1140, 1410 1440, 1470, 1500, 1530, 1560, 1620 and 1680 min
Secondary outcome [4] 298478 0
GIP - blood analysis
Timepoint [4] 298478 0
-30, 0, 30, 60, 120, 180, 420, 480, 660, 900, 1140, 1410 1440, 1470, 1500, 1530, 1560, 1620 and 1680 min
Secondary outcome [5] 298479 0
Pancreatic Polypeptide - blood analysis
Timepoint [5] 298479 0
-30, 0, 30, 60, 120, 180, 420, 480, 660, 900, 1140, 1410 1440, 1470, 1500, 1530, 1560, 1620 and 1680 min
Secondary outcome [6] 298480 0
Insulin blood analysis
Timepoint [6] 298480 0
-30, 0, 30, 60, 90, 120, 180, 420, 480, 660, 900, 1140, 1410, 1440(24hrs), 1470, 1500, 1530, 1560, 1620 and 1680 min
Secondary outcome [7] 298481 0
C-peptide blood analysis
Timepoint [7] 298481 0
-30, 0, 30, 60, 90, 120, 180, 420, 480, 660, 900, 1140, 1410, 1440(24hrs), 1470, 1500, 1530, 1560, 1620 and 1680 min
Secondary outcome [8] 298482 0
Nausea - VAS
Timepoint [8] 298482 0
0, 30,45,60,75,90,120,150,180,210,240,300,360,450,510,630,690,810,930,1050,1170,1140, 1470,1500,1530,1560,1590,1650 mins
Secondary outcome [9] 298483 0
appetite - VAS
Timepoint [9] 298483 0
0, 30,45,60,75,90,120,150,180,210,240,300,360,450,510,630,690,810,930,1050,1170,1140, 1470,1500,1530,1560,1590,1650 mins

Eligibility
Key inclusion criteria
1.Healthy
2.Normal gastric functioning
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Hospital pharmacy (separate department) uses a web based randomisation program called research randomiser(www.randomizer.org) to allocate when the intervention is given
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285692 0
Government body
Name [1] 285692 0
National Health and Medical Research Council
Country [1] 285692 0
Australia
Primary sponsor type
Individual
Name
Mahesh Umapathysivam
Address
Intensive Care Research
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 284520 0
Individual
Name [1] 284520 0
Adam Deane
Address [1] 284520 0
Intensive Care Research
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country [1] 284520 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287689 0
Royal Adelaide Hospital Research Ethics Committe
Ethics committee address [1] 287689 0
Research Ethics Committee,
Level 3, Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Ethics committee country [1] 287689 0
Australia
Date submitted for ethics approval [1] 287689 0
Approval date [1] 287689 0
30/05/2012
Ethics approval number [1] 287689 0
120433

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34479 0
Address 34479 0
Country 34479 0
Phone 34479 0
Fax 34479 0
Email 34479 0
Contact person for public queries
Name 17726 0
Mahesh Umapathysivam
Address 17726 0
Intensive Care Research
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 17726 0
Australia
Phone 17726 0
+61 433 681 614
Fax 17726 0
Email 17726 0
[email protected]
Contact person for scientific queries
Name 8654 0
Mahesh Umapathysivam
Address 8654 0
Intensive Care Research
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 8654 0
Australia
Phone 8654 0
+61 433 681 614
Fax 8654 0
Email 8654 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIComparative Effects of Prolonged and Intermittent Stimulation of the Glucagon-Like Peptide 1 Receptor on Gastric Emptying and Glycemia2014https://doi.org/10.2337/db13-0893
N.B. These documents automatically identified may not have been verified by the study sponsor.