Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000600842
Ethics application status
Approved
Date submitted
4/06/2012
Date registered
4/06/2012
Date last updated
4/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to determine the effects of nutrient-containing pellets on the release of gut hormones, and blood glucose and appetite control, in patients with type 2 diabetes
Scientific title
A randomised, double-blind, placebo-controlled study to determine the effects of enterically coated, nutrient-containing (CTM#3) pellets on the release of gastrointestinal peptides, glycaemic control and sensations of appetite in patients with type 2 diabetes
Secondary ID [1] 280605 0
Royal Adelaide Hospital Protocol number 070916d
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 286618 0
Condition category
Condition code
Metabolic and Endocrine 286891 286891 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each subject will undergo 2 study days, in double-blinded, randomised fashion, separated by 3 days. Two days prior to the first study day, subjects will cease taking metformin, if they usually use this drug. On each study day, subjects will be given a test meal ("breakfast"), consisting of pancakes, butter, golden syrup and apple puree (71 g carbohydrate, 4.3 g protein, 12 g fat, 415 kcal), and 100 mL water, and containing 5g of either enterically coated pellets containing lauric acid ("CTM#3") and paracetamol (as a maker of lauric acid release) or placebo pellets. A second identical test meal (“lunch”) will be consumed 4 hours after breakfast, and will again contain 5g of either CTM#3 or placebo pellets. Those who receive CTM#3 at breakfast will also receive it at lunch, and the same for placebo.
Intervention code [1] 284997 0
Treatment: Drugs
Comparator / control treatment
Enterically coated placebo pellets containing paracetamol but no lauric acid.
Control group
Placebo

Outcomes
Primary outcome [1] 287243 0
Blood glucose concentrations
Timepoint [1] 287243 0
0, 15, 30, 60, 90, 120, 150, 180, 240, 255, 270, 300, 330, 360, 390, 420, and 480 minutes after breakfast.
Secondary outcome [1] 297724 0
Insulin, glucagon-like peptide 1 (GLP-1), and glucagon plasma concentrations
Timepoint [1] 297724 0
0, 15, 30, 60, 90, 120, 150, 180, 240, 255, 270, 300, 330, 360, 390, 420, and 480 minutes after breakfast.
Secondary outcome [2] 297725 0
Sensations of appetite evaluated using a visual analogue questionnaire
Timepoint [2] 297725 0
2 minutes before breakfast, and 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 255, 270, 285, 300, 330, 360, 390, 420, 450 and 480 minutes after breakfast.

Eligibility
Key inclusion criteria
Type 2 diabetes, treated by diet alone or metformin; Body mass index (BMI) 25 - 35 kg/m2; glycated haemoglobin (HbA1c) <8.5%.
Minimum age
21 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Requirement for insulin therapy; Use of any medication that may influence gastrointestinal function within 48 hours of the study; Intake of >20 g alcohol on a daily basis, or cigarette smoking; History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy); Unstable cardiac disease, other serious illness or a cardiovascular or cerebrovascular event within the last 3 months; Postural hypotension (defined by a standing systolic blood pressure < 110mmHg or standing diastolic blood pressure < 60mmHg); Impaired renal or liver function (as assessed by calculated creatinine clearance < 90 mL/min or abnormal liver function tests (>2 times upper limit of normal)); Allergy to paracetamol or sitagliptin; Donation of blood within the previous 3 months; Inability to monitor blood glucose at home with a glucometer; Pregnancy or lactation (the former verified by urine testing in women of reproductive age; in women who are not pregnant or lactating, the study will be completed during the follicular phase of the menstrual cycle); Haemoglobin below lower limit of normal (135 g/L for mean, 115 g/L for women), or ferritin below lower limit of normal (10 mcg/L).

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
3/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285367 0
Commercial sector/Industry
Name [1] 285367 0
Meyer Nurticeuticals
Country [1] 285367 0
United States of America
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 284221 0
None
Name [1] 284221 0
Address [1] 284221 0
Country [1] 284221 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287383 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 287383 0
Level 3, Hanson Institute Royal Adelaide Hospital, North Terrace, Adelaide SA 5000
Ethics committee country [1] 287383 0
Australia
Date submitted for ethics approval [1] 287383 0
31/03/2009
Approval date [1] 287383 0
14/04/2009
Ethics approval number [1] 287383 0
070916d

Summary
Brief summary
The purpose of the study is to determine the effects of enterically coated, nutrient-containing (CTM#3) pellets on glycaemic control, the release of gastrointestinal peptides, and sensations of appetite in patients with type 2 diabetes
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34254 0
Address 34254 0
Country 34254 0
Phone 34254 0
Fax 34254 0
Email 34254 0
Contact person for public queries
Name 17501 0
A/Prof Chris Rayner
Address 17501 0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 17501 0
Australia
Phone 17501 0
+61 8 82222916
Fax 17501 0
+61 8 82233870
Email 17501 0
[email protected]
Contact person for scientific queries
Name 8429 0
A/Prof Chris Rayner
Address 8429 0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 8429 0
Australia
Phone 8429 0
+61 8 82222916
Fax 8429 0
+61 8 82233870
Email 8429 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 AIA randomised trial of enteric-coated nutrient pellets to stimulate gastrointestinal peptide release and lower glycaemia in type 2 diabetes2013https://doi.org/10.1007/s00125-013-2876-2
N.B. These documents automatically identified may not have been verified by the study sponsor.