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Trial registered on ANZCTR


Registration number
ACTRN12611000071921
Ethics application status
Approved
Date submitted
17/01/2011
Date registered
19/01/2011
Date last updated
25/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised placebo controlled crossover trial to evaluate the effects of different doses of taurocholic acid in an enema formulation on gastrointestinal hormone secretion and appetite in healthy humans for the future design of treatments for Type 2 diabetes mellitus and obesity
Scientific title
A randomised placebo controlled crossover trial to evaluate the effects of different doses of taurocholic acid in an enema formulation on gastrointestinal hormone secretion and appetite in healthy humans for the future design of treatments for Type 2 diabetes mellitus and obesity
Secondary ID [1] 253429 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 260974 0
Designing future treatments for obesity 260975 0
Condition category
Condition code
Metabolic and Endocrine 259110 259110 0 0
Diabetes
Diet and Nutrition 259111 259111 0 0
Obesity
Oral and Gastrointestinal 259132 259132 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each healthy volunteers will undergo three treatments (2 with different doses of taurocholic acid 1500mg and 3500mg and one with control), in double-blind, randomised fashion, separated by 3 - 7 days. On each day the test material will be administered as an enema, and each session will last 210 min.
Intervention code [1] 257872 0
Treatment: Drugs
Intervention code [2] 257890 0
Prevention
Comparator / control treatment
Enema containing vehicle only
Control group
Placebo

Outcomes
Primary outcome [1] 261962 0
Plasma concentrations of glucagon-like peptide- 1 (GLP-1), Peptide YY (PYY), and oxyntomodulin
Timepoint [1] 261962 0
T= -5, 10, 30, 60, 90, 120, 180 min, where the enema is administered at T=0 min
Secondary outcome [1] 268886 0
Appetite scores by visual analogue questionnaire
Timepoint [1] 268886 0
T= -5, 10, 30, 60, 90, 120, 180 min, where the enema is administered at T=0 min
Secondary outcome [2] 268887 0
Food intake from an ad libitum buffet meal
Timepoint [2] 268887 0
Offered over 30 minutes, from 180 - 210 min after the enema is administered

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
Gender
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
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)
SA

Funding & Sponsors
Funding source category [1] 258339 0
Government body
Name [1] 258339 0
National Health and Medical Research Council
Address [1] 258339 0
National Health and Medical Research Council
GPO Box 1421 Canberra ACT 2601
Country [1] 258339 0
Australia
Funding source category [2] 258340 0
Commercial sector/Industry
Name [2] 258340 0
Satiogen Pharmaceuticals Inc.
Address [2] 258340 0
Satiogen Pharmaceuticals Inc. 350 Tenth Ave,
Suite 820 San Diego, CA 92101
Country [2] 258340 0
United States of America
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace Adelaide South Australia 5000
Country
Australia
Secondary sponsor category [1] 257494 0
None
Name [1] 257494 0
Address [1] 257494 0
Country [1] 257494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260316 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 260316 0
Level 3, Hanson Institute Royal Adelaide
Hospital, North Terrace, Adelaide SA 5000
Ethics committee country [1] 260316 0
Australia
Date submitted for ethics approval [1] 260316 0
Approval date [1] 260316 0
24/12/2010
Ethics approval number [1] 260316 0
101205

Summary
Brief summary
The study aims to establish whether taurocholic acid, administered as an enema, can stimulate secretion of the gut peptides GLP-1, PYY, and oxyntomodulin, and suppress subsequent appetite and food intake. This information could be useful in designing treatments for type 2 diabetes and obesity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32102 0
A/Prof Chris Rayner
Address 32102 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 32102 0
Australia
Phone 32102 0
+61 8 82222916
Fax 32102 0
+61 8 82233870
Email 32102 0
chris.rayner@adelaide.edu.au
Contact person for public queries
Name 15349 0
A/Prof A/Prof Chris Rayner
Address 15349 0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 15349 0
Australia
Phone 15349 0
+61 8 82222916
Fax 15349 0
+61 8 82233870
Email 15349 0
chris.rayner@adelaide.edu.au
Contact person for scientific queries
Name 6277 0
A/Prof A/Prof Chris Rayner
Address 6277 0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 6277 0
Australia
Phone 6277 0
+61 8 82222916
Fax 6277 0
+61 8 82233870
Email 6277 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