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.

Phase 4

• Conditions: Physiological study to investigate the effects of intraduodenal fat in healthy volunteers.Outcomes may have implications for type 2 diabetes and obesity.; Physiological study to investigate the effects of intraduodenal fat in healthy volunteers.; Outcomes may have implications for type 2 diabetes and obesity.; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12610001104044
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 16

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 phosphatase30 - 110 U/l
Aspartate transaminase0 - 45 U/l
Bilirubin6 - 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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[t= 180, meals will be weighed after 30 minutes of eating.]

Secondary Outcome Measures

Name	Time	Method
Total and active plasma concentrations of GLP-1, PYY, and GIP will be evaluated using radioimmunoassays.[t = -60, 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 165 and 180 minutes];Blood glucose, glucagon and insulin concentrations will be determined using immunoassays.[t = -60, 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 165 and 180 minutes];Plasma triglyceride and free fatty acid concentrations will be determined using blood analysis assays.[t = -60, 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 165 and 180 minutes];Fat oxidation, determined by respiratory quotient[t= -60-120 minutes]