Trial Review

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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
Sex
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
1/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
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
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
[email protected]
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
[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
No additional documents have been identified.