Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001104044
Ethics application status
Approved
Date submitted
15/12/2010
Date registered
16/12/2010
Date last updated
16/12/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of dipeptidyl peptidase IV (DPP-IV) inhibition (vildagliptin) on plasma concentrations of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) during intraduodenal fat infusion.
Scientific title
Does dipeptidyl peptidase IV (DPP-IV) inhibition (vildagliptin) potentiate the effects of intraduodenal fat on glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP), and thereby reduce energy intake and postprandial triglycerides, and increase energy expenditure and fat oxidation in healthy lean males?
Secondary ID [1] 253302 0
N/A
Universal Trial Number (UTN)
U1111-1118-5349
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physiological study to investigate the effects of intraduodenal fat in healthy volunteers.
Outcomes may have implications for type 2 diabetes and obesity. 258834 0
Condition category
Condition code
Oral and Gastrointestinal 258972 258972 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following enrolment, each volunteer will be studied on 2 occasions, in a crossover design, with a double-blind, randomized order, to evaluate the effects of intraduodenal infusion of fat (10 % Intralipid (Fresenius Kabi Pty. Ltd., Hornsby, NSW, Australia), 2.9 kcal/min, infusion rate: 2.6 ml/min):
(i) following oral ingestion of 1 * Galvus tablet (50 mg vildagliptin)
(ii) following oral ingestion of 1 * matched placebo tablet
on blood glucose, plasma insulin, glucagon, GLP-1 (total and active), GIP (total and active), PYY (total and active) concentrations, appetite perceptions and energy intake, triglyceride and free fatty acid concentrations, energy expenditure and fat oxidation.
A 1 week break will be required between each of the two study days.
Intervention code [1] 257750 0
Treatment: Other
Intervention code [2] 257758 0
Treatment: Drugs
Comparator / control treatment
Placebo, identical in taste and appearance, but minus the active constituent.
The placebo will be taken on one occasion only, prior to intraduodenal infusion of fat.
Control group
Placebo

Outcomes
Primary outcome [1] 259827 0
Energy intake will be assessed by quantifying the amount of food consumed at an ad libitum buffet-meal. Meals will be weighed before and after consumption.
Timepoint [1] 259827 0
t= 180, meals will be weighed after 30 minutes of eating.
Secondary outcome [1] 268655 0
Total and active plasma concentrations of GLP-1, PYY, and GIP will be evaluated using radioimmunoassays.
Timepoint [1] 268655 0
t = -60, 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 165 and 180 minutes
Secondary outcome [2] 268656 0
Blood glucose, glucagon and insulin concentrations will be determined using immunoassays.
Timepoint [2] 268656 0
t = -60, 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 165 and 180 minutes
Secondary outcome [3] 268657 0
Plasma triglyceride and free fatty acid concentrations will be determined using blood analysis assays.
Timepoint [3] 268657 0
t = -60, 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 165 and 180 minutes
Secondary outcome [4] 268658 0
Fat oxidation, determined by respiratory quotient
Timepoint [4] 268658 0
t= -60-120 minutes

Eligibility
Key inclusion criteria
Normal body weight for height (BMI: 19 - 25 kg/m2),
Aged 18-55
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Each participant will be questioned at a screening visit prior to their enrolment in the study to exclude:
significant gastrointestinal symptoms; disease or surgery
current use of any prescribed or non-prescribed medications
diabetes mellitus
epilepsy
cardiovascular or respiratory disease
any other significant illness as assessed by the investigator
allergy to local anaesthetic
intake of > 20 g alcohol on a daily basis
smokers (cigarettes, cigars, marijuana)
restrained eaters, as determined by a score of > 12 on the eating restraint component of the Three Factor Eating Questionnaire.
donation of blood in the 12 weeks prior to enrolment in the study. Participants will also be instructed to abstain from donating blood for 12 weeks after study completion. A screening blood sample will be taken to ensure that only individuals with normal haemoglobin and iron levels are included in the study.
consumption of a vegetarian diet
high performance athletes
claustrophobia in confined spaces
unable to comprehend study protocol
known lactose intolerance
liver function tests and creatinine clearance outside the following ranges
Alanine aminotransferase (ALT) 0 -55 U/l
Alkaline phosphatase 30 - 110 U/l
Aspartate transaminase 0 - 45 U/l
Bilirubin 6 - 24 mmol/l
Calculated creatinine clearance will be determined as follows:
Cr clearance = [140 - age (years) x weight (kg)] / serum creatinine (micromol/L)
Subjects with a creatinine clearance cut-off of <50 ml/min AND/OR serum creatinine concentration >0.12mmol/l will be excluded.

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)
The study is a double-blind crossover study. Each participant will receive both study drug and placebo. The study drug will be dispensed by the pharmacy, so that neither the volunteer, nor the investigators will know which treatment has been administered. Pharmacy will receive the drug and randomisation allocation.
Placebo and active drug will be matched for appearance.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random block allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258218 0
Commercial sector/Industry
Name [1] 258218 0
Novartis Pharmaceuticals Australia Pty. Ltd.
Country [1] 258218 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide
South Australia
5000
Country
Australia
Secondary sponsor category [1] 257387 0
University
Name [1] 257387 0
University of Adelaide
Address [1] 257387 0
North Terrace
Adelaide, SA
5005
Country [1] 257387 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260200 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 260200 0
Level 3, Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide, SA
5000
Ethics committee country [1] 260200 0
Australia
Date submitted for ethics approval [1] 260200 0
14/09/2010
Approval date [1] 260200 0
09/11/2010
Ethics approval number [1] 260200 0
101008

Summary
Brief summary
When we ingest a meal a number of hormones are released from the small intestine. These hormones play an important role in regulating the motor function of the gut, the levels of sugar and fat in the blood, and the rate at which the body uses energy. The effects of these hormones on these factors may, however, be limited by the fact that they undergo rapid degradation by an enzyme in the blood. There is a new class of drugs that act by inhibiting this enzyme, and as a result, these drugs improve blood glucose levels in type 2 diabetic patients by increasing active concentrations of these hormones following glucose ingestion. It is currently unclear how these drugs will influence concentrations of these gastrointestinal peptides following fat intake, and that is what this study is designed to investigate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32019 0
Address 32019 0
Country 32019 0
Phone 32019 0
Fax 32019 0
Email 32019 0
Contact person for public queries
Name 15266 0
Tanya Little
Address 15266 0
University of Adelaide Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide, SA
5000
Country 15266 0
Australia
Phone 15266 0
+61 8 8222 0724
Fax 15266 0
Email 15266 0
[email protected]
Contact person for scientific queries
Name 6194 0
Tanya Little
Address 6194 0
University of Adelaide Discipline of Medicine
Level 6, Eleanor Harrald Building
Royal Adelaide Hospital
North Terrace
Adelaide, SA
5000
Country 6194 0
Australia
Phone 6194 0
+61 8 8222 0724
Fax 6194 0
Email 6194 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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