More or less? The impact of colesevelam on bile acids and glycaemic control in type 2 diabetes

The University of Adelaide0 个研究点目标入组 25 人开始时间: 2021年7月7日最近更新: 2023年5月15日

适应症

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•Type 2 diabetes (World Health Organisation (WHO) criteria) treated by metformin only (on a stable dose over the last 3 months)
•Body mass index (BMI) from 25 to 35 kg/m2
•Males and females, aged from 40 to 79 years
•Glycated haemoglobin (HbA1c) less than 7.9%
•Haemoglobin above the lower limit of the normal range (ie. above 135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (ie. above 30ng/mL for men and above 20mg/mL for women)

•Use of any medication that may influence gastrointestinal motor function, body weight or appetite (opiates, anticholinergics, levodopa, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, prucalopride, or erythromycin)
•Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
•History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
•Other significant illness, including epilepsy, cardiovascular or respiratory disease
•Impaired renal or liver function (as assessed by calculated creatinine clearance less than 90 mL/min or abnormal liver function tests (more 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
•Female participants who are pregnant or planning for pregnancy, or are lactating
•Vegetarians

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