ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12608000562370

Ethics application status

Approved

Date submitted

15/09/2008

Date registered

7/11/2008

Date last updated

7/12/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

The effects of exogenous glucagon-like peptide-1 administration on glucose metabolism and gastric emptying in critically ill patients.

Scientific title

Double-blind randomised placebo cross-over trial of exogenous glucagon-like peptide-1 to establish the effect on glucose metabolism and gastric emptying during gastric feeding in critically ill patients

Secondary ID [1]

There is no secondary ID

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Critical illness

Condition category

Condition code

Metabolic and Endocrine

Other metabolic disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intravenous Glucagon-like peptide-1 (reconstituted in 4%albumin) at 1.2pmol/kg/min will be administered for 360minutes at 1ml/min. Seperated by 24 hours the cross-over treatment is placebo (intravenous 4% Albumin at 1ml/min for 360minutes

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

placebo (4% albumin solution intravenous for 360minutes at 1ml/min)

Control group

Active

Outcomes

Primary outcome [1]

blood glucose concentration. Measured using bedside glucometer

Timepoint [1]

0-6 hours

Primary outcome [2]

gastric emptying. Measured using scintigraphic and breath test techniques

Timepoint [2]

0-8 hours

Primary outcome [3]

nutrient absorption. Measured using absorption of 3-O-Methyl-Glucose.

Timepoint [3]

0-4 hours

Secondary outcome [1]

Regulatory and counter-regulatory hormone release. Measured using plasma Insulin and glucagon concentrations

Timepoint [1]

0-6 hours

Secondary outcome [2]

plasma GLP-1 concentration

Timepoint [2]

0-6 hours

Eligibility

Key inclusion criteria

critically ill patients and mechanically ventilated suitable for, or receiving, enteral nutrition and likely to stay ventilated for at least 48 hours.

Minimum age

17 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Pregnancy, Contraindication to enteral nutrient administration, Previous surgery on the oesophagus, stomach or duodenum, Any gastrointestinal surgery on this hospital admission and History of diabetes mellitus

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)

Cross-over study. Randomisation is performed by the pharmacy department of the Royal Adelaide Hospital using statistical software. Once the peptide is reconstituted the study drug or placebo is packaged and labelled study drug. The investigator will receive the study drug from the pharmacy department and have no involvement in preparation of solution or randomisation schedule.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

computer generated

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Phase 1

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

31/10/2008

Actual

4/11/2008

Date of last participant enrolment

Anticipated

31/10/2013

Actual

27/07/2009

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

Level 5, 20 Allara Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Adelaide Hospital Intensive Care Unit

Address

Floor 4
Royal Adelaide Hospital
North Terrace
Adelaide
5000 SA

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

adam deane

Address [1]

Floor 4
Royal Adelaide Hospital
North Terrace
Adelaide 5000
SA

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Research Ethics Committee

Ethics committee address [1]

IMVS Building
Royal Adelaide Hospital 
North Terrace
Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/07/2008

Ethics approval number [1]

061229 V3

Ethics committee name [2]

Royal Adelaide Hospital Research Ethics Committee

Ethics committee address [2]

Ethics committee country [2]

Date submitted for ethics approval [2]

Approval date [2]

30/07/2008

Ethics approval number [2]

061229c

Summary

Brief summary

Adequate nutrition is important to allow patients in the Intensive Care Unit the best chance to recover from their illness. The most common method of feeding patients is through a tube into the gut. However, due to their illness many of these patients have very high levels of glucose (sugar) in the bloodstream, which can have a negative effect on their recovery.   The purpose of this study is to determine whether a naturally occurring hormone, called Glucagon-like Peptide-1 (GLP-1), can help lower blood glucose levels and improve the outcome of patients in Intensive Care. GLP-1 is a gastrointestinal hormone that is normally released into the bloodstream in response to a meal.

Trial website

Trial related presentations / publications

Deane AM, Chapman MJ, Fraser RJ, Summers MJ, Zaknic AV, Storey JP, Jones KL, Rayner CK, Horowitz M. Effects of exogenous glucagon-like peptide-1 on gastric emptying and glucose absorption in the critically ill: relationship to glycemia. Crit Care Med. 2010 May;38(5):1261-9.

Public notes

Contacts

Principal investigator

Name

Dr Adam Deane

Address

Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000

Country

Australia

Phone

+618 8222 2818

Fax

adam.deane@adelaide.edu.au

Contact person for public queries

Name

Adam Deane

Address

Intensive Care Unit
Floor 4
Royal Adelaide Hospital
North Terrace
Adelaide SA
5000

Country

Australia

Phone

08 8222-4000

Fax

adam.deane@adelaide.edu.au

Contact person for scientific queries

Name

adam deane

Address

Intensive Care Unit
Floor 4
Royal Adelaide Hospital
North Terrace
Adelaide
SA
5000

Country

Australia

Phone

08 8222-4000

Fax

adam.deane@adelaide.edu.au

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

Source	Title	Year of Publication	DOI
Embase	The effects of exogenous glucagon-like peptide-1 on glycaemia and gastric emptying in the critically ill.	2009

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically