The effect of resveratrol supplementation on gut hormone secretion, gastric emptying, and blood glucose responses to meals in patients with type 2 diabetes
- Conditions
- type 2 diabetes mellitusMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12613000717752
- Lead Sponsor
- Royal Adelaide Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
Patients with a diagnosis of type 2 diabetes by WHO criteria (plasma glucose 7 mmol/L or greater fasting, or 11.1 mmol/L or greater two hours after a glucose challenge) or with a history of HbA1c 6.5% or greater, managed by diet alone.
- Body mass index (BMI) 20 - 35 kg/m2
- Age 20 – 75 years
- Males and post-menopausal females (the latter based on history).
- HbA1c 7.9% or less
- Haemoglobin above the lower limit of the normal range (ie. >130g/L in males and 120g/L in females) and ferritin above the lower limit of normal (ie. >15 mcg/L in females and 30 mcg/L in males)
- Use of any medication, within a period of 5 half-lives or less before the study, that may influence gastrointestinal motor function (eg: opiates, anticholinergics, levodopa, calcium-channel antagonists, beta blockers, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, tegaserod, or erythromycin).
- Intake of > 20 g alcohol on a daily basis, or cigarette smoking
- Inability to tolerate the standardized meals (eg. strict vegetarians, subjects with food allergies such as egg allergy, and those on a gluten-free diet).
- History of gastrointestinal disease, including chronic abdominal symptoms or a diagnosis of gastroparesis
- Unstable cardiac disease, specifically those with cardiac symptoms such as angina or dyspnea, not adequately controlled by medications.
- Impaired renal function (eGFR of <60 mL/min/1.73 m2).
- Impaired liver function (liver enzymes twice the upper limit of normal or greater).
- Donation of blood within the previous 3 months
- Participation in any other research studies within the previous 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma total GLP-1 concentrations[Concentrations measured at T = -5, 15, 30, 45, 60, 90, 120, 150, 180 and 240 min in relation to consumption of the test meal at T = 10 min]
- Secondary Outcome Measures
Name Time Method Gastric half-emptying time as measured by 13C-octanoic breath test[Breath samples collected at T=5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 min and then every 15 min until T = 240 min];Blood glucose concentrations[Concentrations measured at T = -5, 15, 30, 45, 60, 90, 120, 150, 180 and 240 min in relation to consumption of the test meal at T = 10 min]