None listed
Conditions
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.
Interventions
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),
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.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Normal body weight for height (BMI: 19 - 25 kg/m2), Aged 18-55
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.
Outcome results
None listed