ISRCTN12008159已完成未知
The effect of increased sodium intake with a carbohydrate-rich meal on glucose homeostasis in subjects without diabetes after bariatric surgery: A proof-of-concept, randomised, open-label, crossover study
niversity of Leicester0 个研究点目标入组 12 人开始时间: 2020年7月23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
- 12
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 but less than 75 years old
- •2. Subjects >=1 year after gastric bypass (RYGB)
- •3. Able to understand written and spoken English
- •4. Able to give informed consent
排除标准
- •1. Use of any glucose-lowering medication (including insulin)
- •2. Adrenal insufficiency and/or substitution with glucocorticoids
- •3. eGFR <=60 ml/min/173 m²
- •4. Recent active infection (an active infection will be any infection over the last 10 days)
- •5. Current use of steroids
- •6. Known liver cirrhosis or ALT >2 times above upper normal limit
- •7. Known primary or secondary hyperaldosteronism
- •8. Moderate or severe hypertension during screening visit (Systolic Blood Pressure >160 mmHg as average of 3 measurements)
- •9. Established diagnosis of congestive heart failure
- •10. Significant peripheral oedema on clinical examination at screening visit
- •11. People with allergy or intolerance to the mixed meal tolerance test (eg, milk protein allergy, lactose and gluten intolerance)
- •12. People following a vegan diet (mixed meal tolerance test not suitable for those following a vegan diet)
- •13. Other bariatric procedure except of RYGB
- •14. Previous revisional bariatric surgery
- •15. Currently pregnant or breastfeeding
- •16. Patients with history of Type 1 or Type 2 Diabetes
- •17. Patients with diagnosis of Epilepsy
- •18. HbA1C >=65% or >=48 mmol/l at screening blood tests
- •19. Haemoglobin (Hb) <100 g/l at screening blood tests
- •20. Participating in another research study involving intervention within 3 months of screening
- •21. Having a formal previous diagnosis of postprandial hypoglycaemia
- •22. Being on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia
- •23. 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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