None listed
Conditions
Brief summary
Resveratrol, which is a nutritional supplement derived from certain plant foods including red grapes, has the potential to improve blood sugar levels in patients with type 2 diabetes by uncertain mechanisms. In this study, we aim to identify the effects of resveratrol on the rate of gastric emptying, blood sugar levels and blood levels of hormones produced by the intestines
Interventions
Each patient will undergo two 5 week treatment periods, one with resveratrol 500mg capsules twice daily and one with placebo, in double- blind, randomised fashion, separated by 5 weeks. They will attend the laboratory on the first and last day of each treatment period to consume a mashed potato meal labelled with 13C-octanoic acid. Compliance will be monitored by capsule counts at each study visit and by twice weekly telephone calls.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- 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)
Exclusion criteria
- 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
Outcome results
None listed