None listed
Conditions
Brief summary
The human gut secretes a number of hormones to regulate food intake and blood sugar. Ghrelin is a hormone secreted from the stomach before meals, which promotes food intake. Glucagon-like peptide-1 (GLP-1) is secreted from the small and large intestines after meals, and is known to suppress food intake and improve blood sugar control. In this trial, we want to investigate whether saline solutions administered into the small intestine will affect the secretion of ghrelin and GLP-1, and the sensation of hunger and satiety.
Interventions
Following enrolment, each subject will be studied on two occasions, separated by at leaste 7 days, in a double-blind, randomised order. On each study day, following correct positioning of the intraduodenal catheter, 4 baseline samples will be drawn (at t = -45, -30, -15 and 0 min), followed by an intraduodenal infusion of either isotonic saline (300mOsm) or hypertonic saline (1500mOsm) at a rate of 4 ml/min for 45 min (t=0-45 min). Blood samples will be collected for another 3 hours (at t = 15,
Following enrolment, each subject will be studied on two occasions, separated by at leaste 7 days, in a double-blind, randomised order. On each study day, following correct positioning of the intraduodenal catheter, 4 baseline samples will be drawn (at t = -45, -30, -15 and 0 min), followed by an intraduodenal infusion of either isotonic saline (300mOsm) or hypertonic saline (1500mOsm) at a rate of 4 ml/min for 45 min (t=0-45 min). Blood samples will be collected for another 3 hours (at t = 15, 30, 45, 60, 75, 90, 120 and 180 min). At t = 180 min, the intraduodenal catheter will be removed, and a cold buffet meal will be given for evaluation of energy intake.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) 20 - 25 kg/m2 * Males (to avoid the effect of the menstrual cycle on gut hormone secretion) * Glycated haemoglobin (HbA1c) less than or equal to 6.0% * Haemoglobin above the lower limit of the normal range (i.e. greater than 135g/L), and ferritin above the lower limit of normal (i.e. greater than 10microg/L)
Exclusion criteria
* Use of any medication that may influence BP, gastrointestinal motor function, body weight or appetite (e.g. antihypertensive drugs, domperidone and cisapride, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St. John's Wort etc.) * Evidence of drug abuse, consumption of tobacco in any form or daily consumption of more than 20 g alcohol * History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendectomy) * Restrained eaters [score greater than or equal to 12 on the eating restraint component of the Three-Factor Eating Questionnaire * Other significant illness, including epilepsy, cardiovascular or respiratory disease * Autonomic nerve damage (as assessed by standardised cardiovascular reflex tests * Impaired renal or liver function (as assessed by calculated creatinine clearance less than 90 mL/min or abnormal liver function tests (greater than 2 times upper limit of normal range)) * Donation of blood within the previous 3 months * Participation in any other research studies within the previous 3 months * Inability to give informed consent * Allergy to local anaesthetic * Vegetarians
Outcome results
None listed