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Trial registered on ANZCTR


Registration number
ACTRN12611000775910
Ethics application status
Approved
Date submitted
22/07/2011
Date registered
22/07/2011
Date last updated
27/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial to evaluate the effects of different monosaccharide preloads on incretin hormone secretion, gastric emptying and post-meal blood glucose in healthy subjects and patients with type 2 diabetes mellitus.
Scientific title
A randomised placebo controlled crossover trial to evaluate the effects of different monosaccharide preloads on incretin hormone secretion, gastric emptying and postprandial glycaemia in healthy subjects and patients with type 2 diabetes mellitus.
Secondary ID [1] 262685 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 268389 0
Condition category
Condition code
Metabolic and Endocrine 268530 268530 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each subject will undergo four studies, in which they will receive a sweet "preload" drink, containing either 40g glucose, 40g 3-O-methylglucose, 40g Tagatesse, or 60mg sucralose (placebo control) in double-blind, randomised fashion, separated by 3 - 7 days, consumed between T=-22 to -20 min, before a mashed potato meal consumed between T=-5 to 0 min.
Intervention code [1] 267034 0
Treatment: Other
Comparator / control treatment
60mg sucralose drink
Control group
Placebo

Outcomes
Primary outcome [1] 269276 0
Plasma GLP-1 concentration
Timepoint [1] 269276 0
T=-25, -10, 0, 15, 30, 60, 90, 120, and 240 min
Secondary outcome [1] 279268 0
Blood glucose concentration
Timepoint [1] 279268 0
T=-25, -10, 0, 15, 30, 60, 90, 120, and 240 min
Secondary outcome [2] 279269 0
Gastric half-emptying time measured by breath test after labelling the potato meal with 13C octanoic acid
Timepoint [2] 279269 0
Breath samples at immediately before the potato meal and then every 5 min for the first hour after, then every 15 min for a further 3 hours.
Secondary outcome [3] 279270 0
Sensations of hunger and fullness by visual analog scales
Timepoint [3] 279270 0
T=-25, -10, 0, 15, 30, 60, 90, 120, and 240 min

Eligibility
Key inclusion criteria
Healthy volunteers and patients with type 2 diabetes mellitus
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medications affecting gut function; Alcohol intake >20g daily or cigarette smoking; Significant gastrointestinal disease or surgery; Impaired liver or renal function; Blood donation within 3 months

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/02/2010
Actual
24/02/2010
Date of last participant enrolment
Anticipated
Actual
3/05/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267508 0
Government body
Name [1] 267508 0
National Health and Medical Research Council
Country [1] 267508 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace Adelaide South Australia 5000
Country
Australia
Secondary sponsor category [1] 266549 0
None
Name [1] 266549 0
Address [1] 266549 0
Country [1] 266549 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269471 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 269471 0
Ethics committee country [1] 269471 0
Australia
Date submitted for ethics approval [1] 269471 0
Approval date [1] 269471 0
22/10/2009
Ethics approval number [1] 269471 0
RAH protocol no. 091014

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32911 0
A/Prof Chris Rayner
Address 32911 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 32911 0
Australia
Phone 32911 0
+61 8 82222916
Fax 32911 0
+61 8 82233870
Email 32911 0
[email protected]
Contact person for public queries
Name 16158 0
A/Prof Chris Rayner
Address 16158 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 16158 0
Australia
Phone 16158 0
+61 8 82222916
Fax 16158 0
+61 8 82233870
Email 16158 0
[email protected]
Contact person for scientific queries
Name 7086 0
A/Prof Chris Rayner
Address 7086 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 7086 0
Australia
Phone 7086 0
+61 8 82222916
Fax 7086 0
+61 8 82233870
Email 7086 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 AIEffects of different sweet preloads on incretin hormone secretion, gastric emptying, and postprandial glycemia in healthy humans2011https://doi.org/10.3945/ajcn.111.021543
N.B. These documents automatically identified may not have been verified by the study sponsor.