EUCTR2019-004041-32-GB进行中（未招募）1 期
The effect of Canagliflozin 300mg, in subjects without diabetes after bariatric surgery, on glucose homeostasis (The CONTROL Study): A proof-of-concept, randomised, open-label, two period crossover study. - The CONTROL Study
niversity of Leicester0 个研究点目标入组 24 人开始时间: 2020年7月13日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age=18 years old but less than 75 years old
- •Subjects =1 year after gastric bypass (RYGB) or sleeve gastrectomy (SG)
- •Able to understand written and spoken English
- •Able to give informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Use of any glucose-lowering medication (including insulin)
- •Adrenal insufficiency and/or substitution with glucocorticoids
- •ALT >1.5 times the upper normal limit
- •Moderate to severe renal impairment (eGFR=60 ml/min/1.73m2)
- •Individuals on loop diuretics
- •Participants with established diagnosis of postural hypotension by their GP
- •Recent active infection (over the last 10 days)
- •Current use of steroids
- •Other bariatric procedure except of RYGB/SG
- •Previous revisional bariatric surgery
- •Currently pregnant or breastfeeding
- •Females of child-bearing age, unwilling to use contraception during the period of the study
- •Patients with history of Type 1 or Type 2 diabetes
- •Intolerant to the Mixed Meal Tolerance test.
- •HbA1C = 6.5% or =48mmol/l at screening blood tests
- •Haemoglobin (Hb) <100 g/L at screening blood tests
- •Clinical contraindication to Canagliflozin
- •Known osteoporosis
- •Previous history of Fournier’s gangrene
- •History of epilepsy
- •Known foot ulcers/previous amputation
- •Participating in another research study involving intervention within 3 months of screening
- •Having a formal previous diagnosis of postprandial hypoglycaemia
- •Being on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia
- •Participants without established previous diagnosis of postprandial hyperinsulinaemic hypoglycaemia but with symptoms suggestive of frequent (defined as more than once weekly) AND severe postprandial hypoglycaemia at the screening hypoglycaemia questionnaire (severe is defined as at least 2 symptom on Edinburgh Hypoglycaemia Scale (EHS) Questionnaire with intensity >5 in a scale from 1 to 7) over the last 2 months.
研究者
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