ISRCTN16600471已完成未知
The impact of a fat-rich preload before a carbohydrate-rich meal on glucose homeostasis in patients without diabetes after sleeve gastrectomy: a proof-of-concept, randomized, open-label, crossover study
niversity of Leicester0 个研究点目标入组 10 人开始时间: 2021年3月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged =18 years old
- •2. =1 year after sleeve gastrectomy (SG)
- •3. Able to understand written and spoken English
- •4. Able to give informed consent
- •5. Happy for their GP to be notified of their study participation
排除标准
- •1. Use of any glucose-lowering medication (including insulin)
- •2. Adrenal insufficiency and/or substitution with glucocorticoids
- •3. eGFR =45 ml/min/1.73 m²
- •4. Weight =50 kg
- •5. Recent active infection (an active infection will be any infection over the last 10 days)
- •6. Current use of steroids
- •7. Known liver cirrhosis or ALT >2 times above the upper normal limit
- •8. People with allergy or intolerance to the mixed meal tolerance test (e.g., milk protein allergy, lactose and gluten intolerance), to paracetamol or to nuts
- •9. People who are on regular painkillers (codeine phosphate, paracetamol, morphine or NSAIDS)
- •10. Other bariatric procedure except for SG
- •11. Previous revisional bariatric surgery
- •12. Hb <100 g/l at screening blood tests
- •13. HbA1C =6.5% or =48 mmol/l at screening blood tests
- •14. Currently pregnant or breastfeeding
- •15. Patients with a history of type 1 or type 2 diabetes
- •16. Patients with a diagnosis of epilepsy
- •17. Participating in another research study involving intervention within 3 months of screening
- •18. Having a formal previous diagnosis of postprandial hypoglycaemia
- •19. Currently on metoclopramide, domperidone or colestyramine as they can affect paracetamol absorption as per SPC (Summary of Product Characteristics) for paracetamol
- •20. Currently on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia
- •21. Any concurrent condition, in the judgment of investigator and/or sponsor, that could interfere with the safety and study conduct or interpretation of study results
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