A randomised placebo controlled crossover trial to evaluate the effects of hydroxycitrate (HCA) on blood glucose concentrations, glucose absorption, and plasma GIP and GLP-1 secretion, in response to intraduodenal glucose infusion, in healthy humans and patients with type 2 diabetes mellitus

niversity of Adelaide0 个研究点目标入组 20 人开始时间: 2015年2月3日最近更新: 2020年1月13日

适应症

试验速览

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•Healthy subjects:
•- Males or females aged 18 – 70 years
•- Body mass index (BMI) 19 - 30 kg/m2
•Type 2 diabetes patients:
•Patients with type 2 diabetes
•- Patients with a diagnosis of type 2 diabetes by WHO criteria (plasma glucose greater than or equal to 7 mmol/L fasting, or greater than or equal to 11.1 mmol/L two hours after a glucose challenge) or with a history of HbA1c greater than or equal to 6.5%.
•- Managed by diet alone.
•- HbA1c between 6.0 and 8.5%
•- Body mass index (BMI) 20 - 35 kg/m2
•- Age 18 – 70 years

•- Use of any medication that may influence gastrointestinal motor function within 48 hours or 5 half lives of the study, specifically: 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, erythromycin
•- Intake of >20 g alcohol on a daily basis, or >10 cigarettes per day
•- History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, or previous gastrointestinal surgery (other than uncomplicated appendicectomy)
•- Impaired renal or liver function (as assessed by calculated creatinine clearance < 90 mL/min or abnormal liver function tests)
•- Donation of blood within the previous 3 months
•- Participation of other studies within the previous 3 months

发起方

niversity of Adelaide