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Trial registered on ANZCTR


Registration number
ACTRN12612001131842
Ethics application status
Approved
Date submitted
22/10/2012
Date registered
23/10/2012
Date last updated
23/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial to evaluate the effects of a D-xylose preload, with or without sitagliptin, on incretin hormone secretion, gastric emptying, and postprandial glycaemia in patients with type 2 diabetes mellitus.
Scientific title
A randomised placebo controlled crossover trial to evaluate the effects of a D-xylose preload, with or without sitagliptin, on incretin hormone secretion, gastric emptying, and postprandial glycaemia in patients with type 2 diabetes mellitus.
Secondary ID [1] 281421 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 287671 0
Condition category
Condition code
Metabolic and Endocrine 288012 288012 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each subject will undergo four study visits, in which they will receive a sweet "preload" drink, containing either 50g D-xylose or 80mg sucralose (negative control), after receiving either 100mg sitagliptin or placebo. The four studies will occur in double-blind, randomised fashion, separated by 3 days. Sitagliptin or placebo tablets will be taken at 2200 the evening before each study, and the sweet preload will be consumed the following morning, between T=-40 to -38 min, before a mashed potato meal (65g powdered potato and 20g glucose reconstituted with 200mL water and one egg yolk containing 13C octanoic acid) consumed between T=0 to 5 min.
Intervention code [1] 285918 0
Treatment: Other
Intervention code [2] 285919 0
Treatment: Drugs
Comparator / control treatment
80mg sucralose preload (equivalent sweetness to D-xylose preload); matching placebo tablet (identical to sitagliptin tablet).
Control group
Placebo

Outcomes
Primary outcome [1] 288222 0
Blood glucose concentration
Timepoint [1] 288222 0
T = -40, -20, 0, 15, 30, 60, 90, 120, 180 and 240 min
Secondary outcome [1] 299634 0
Plasma active GLP-1 concentration
Timepoint [1] 299634 0
T = -40, -20, 0, 15, 30, 60, 90, 120, 180 and 240 min
Secondary outcome [2] 299635 0
Gastric half-emptying time measured by breath test after labelling the potato meal with 13C octanoic acid
Timepoint [2] 299635 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.

Eligibility
Key inclusion criteria
Patients with type 2 diabetes mellitus
Minimum age
20 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
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] 286186 0
Government body
Name [1] 286186 0
National Health and Medical Research Council
Address [1] 286186 0
National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601
Country [1] 286186 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace Adelaide South Australia 5000
Country
Australia
Secondary sponsor category [1] 284996 0
None
Name [1] 284996 0
Address [1] 284996 0
Country [1] 284996 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288259 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 288259 0
Level 3, Hanson Institute Royal Adelaide Hospital, North Terrace, Adelaide SA 5000
Ethics committee country [1] 288259 0
Australia
Date submitted for ethics approval [1] 288259 0
Approval date [1] 288259 0
18/11/2011
Ethics approval number [1] 288259 0
110924

Summary
Brief summary
The study will evaluate the effects of a D-xylose preload, with or without sitagliptin, on incretin hormone secretion, gastric emptying, and postprandial glycaemia in patients with type 2 diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34857 0
Address 34857 0
Country 34857 0
Phone 34857 0
Fax 34857 0
Email 34857 0
Contact person for public queries
Name 18104 0
A/Prof Chris Rayner
Address 18104 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 18104 0
Australia
Phone 18104 0
+61 8 82222916
Fax 18104 0
+61 8 82233870
Email 18104 0
chris.rayner@adelaide.edu.au
Contact person for scientific queries
Name 9032 0
A/Prof Chris Rayner
Address 9032 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 9032 0
Australia
Phone 9032 0
+61 8 82222916
Fax 9032 0
+61 8 82233870
Email 9032 0
chris.rayner@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary