Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001213831
Ethics application status
Approved
Date submitted
13/11/2012
Date registered
16/11/2012
Date last updated
16/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised placebo controlled crossover trial to evaluate the effects of intrajejunal taurocholic acid on gastrointestinal hormone secretion and glycaemia in response to intrajejunal glucose infusion in healthy humans for the future design of treatments for type 2 diabetes mellitus
Scientific title
A randomised placebo controlled crossover trial to evaluate the effects of intrajejunal taurocholic acid on gastrointestinal hormone secretion and glycaemia in response to intrajejunal glucose infusion in healthy humans for the future design of treatments for type 2 diabetes mellitus
Secondary ID [1] 281538 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Designing future treatments for type 2 diabetes mellitus 287804 0
Condition category
Condition code
Metabolic and Endocrine 288155 288155 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each healthy volunteer will undergo two treatments (one with taurocholic acid (TCA) 4g and one with control), in double- blind, randomised fashion, separated by 7 days. On each day a small intestinal catheter will be positioned for TCA or control (saline) infusion into the jejunum during both 30 minutes of fasting (2g TCA or saline control) and 120 minutes of concurrent glucose infusion (2g TCA or saline control, together with 60g glucose).
Intervention code [1] 286053 0
Treatment: Drugs
Comparator / control treatment
Saline infusion
Control group
Placebo

Outcomes
Primary outcome [1] 288357 0
Blood glucose concentrations
Timepoint [1] 288357 0
T= -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, and 120 min, where 2g TCA or control is infused between T= -30 to 0 min, and 2g TCA or control plus 60g glucose is infused between T= 0 to 120 min.
Secondary outcome [1] 299946 0
Plasma GLP-1 concentrations
Timepoint [1] 299946 0
T= -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, and 120 min, where 2g TCA or control is infused between T= -30 to 0 min, and 2g TCA or control plus 60g glucose is infused between T= 0 to 120 min.
Secondary outcome [2] 299947 0
Plasma insulin concentrations
Timepoint [2] 299947 0
T= -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, and 120 min, where 2g TCA or control is infused between T= -30 to 0 min, and 2g TCA or control plus 60g glucose is infused between T= 0 to 120 min.

Eligibility
Key inclusion criteria
Healthy subjects; Body mass index (BMI) 19 - 30 kg/m2; Haemoglobin > 135 g/L
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
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
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286319 0
Government body
Name [1] 286319 0
National Health and Medical Research Council
Country [1] 286319 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace Adelaide South Australia 5000
Country
Australia
Secondary sponsor category [1] 285105 0
None
Name [1] 285105 0
Address [1] 285105 0
Country [1] 285105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288389 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 288389 0
Ethics committee country [1] 288389 0
Australia
Date submitted for ethics approval [1] 288389 0
Approval date [1] 288389 0
19/12/2011
Ethics approval number [1] 288389 0
111209

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

Contacts
Principal investigator
Name 34950 0
Address 34950 0
Country 34950 0
Phone 34950 0
Fax 34950 0
Email 34950 0
Contact person for public queries
Name 18197 0
A/Prof Chris Rayner
Address 18197 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 18197 0
Australia
Phone 18197 0
+61 8 82222916
Fax 18197 0
+61 8 82233870
Email 18197 0
[email protected]
Contact person for scientific queries
Name 9125 0
A/Prof Chris Rayner
Address 9125 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 9125 0
Australia
Phone 9125 0
+61 8 82222916
Fax 9125 0
+61 8 82233870
Email 9125 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.