None listed
Conditions
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, gastric emptying and sensations of appetite in patients with type 2 diabetes, when given concurrently with the dipeptidyl dipeptidase IV inhibitor, sitagliptin.
Interventions
Each subject will undergo 2 study days, in double-blinded, randomised fashion, separated by 3 days. Three days prior to the first study day, subjects will cease their usual oral hypoglycaemic agent and commence sitagliptin oral tablet 100 mg each morning (ie. for three full days prior to the first study day). Subjects will remain on sitagliptin 100 mg daily until the second study day is completed, after which they will revert to their usual therapy (ie. they will receive a total of 7 days of sit
Each subject will undergo 2 study days, in double-blinded, randomised fashion, separated by 3 days. Three days prior to the first study day, subjects will cease their usual oral hypoglycaemic agent and commence sitagliptin oral tablet 100 mg each morning (ie. for three full days prior to the first study day). Subjects will remain on sitagliptin 100 mg daily until the second study day is completed, after which they will revert to their usual therapy (ie. they will receive a total of 7 days of sitagliptin). On each study day, subjects will take their daily dose of sitagliptin oral tablet 100 mg. 60 min later they will be given a test meal ("breakfast") 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 , and also 100 mg 13C-octanoic acid, as a marker of gastric emptying. Those who receive CTM#3 at breakfast will also receive it at lunch, and the same for placebo.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Type 2 diabetes, treated by diet alone or single oral hypoglycaemic agent; Body mass index (BMI) 25 - 35 kg/m2; glycated haemoglobin (HbA1c) 7.5% - 9.0%.
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).
Outcome results
None listed