The Effect of Nutrition and Medical Therapy on Post-bariatric Hypoglycemia Patients 2-4 Years After a Roux-en-Y Gastric Bypass: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- blood sugar variation
研究概览
简要总结
This is a pilot study to explore the effect of 'medical nutritional therapy' in patients diagnosed with post-bariatric hypoglycemia (PBH), 2-4 years after gastric bypass surgery. The study is largely inspired by the findings presented in the meta-analyses from Joslin Diabetes Center, where a treatment strategy is proposed to reduce the symptoms of PBH. This treatment strategy is mainly based on clinical observations and experience, while there is little or no objective data to support that this strategy improves PBH. The data from this pilot study can then be used to set up larger studies where a conclusion on treatment of PBH may be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient in Nord-Trøndelag 2-4 years after Roux-en-y gastric bypass surgery
- •visits Namsos outpatient clinic for follow-up.
- •having at least 3 symptoms of hypoglycemia presented in the dumping severity scale (DSS).
- •at least one of these symptoms must be a neuroglycopenic symptom
- •all these symptoms have an intensity of 2 or 3 on DSS.
排除标准
- •severe surgery-related complication
- •revisional surgery
- •life threatening health conditions.
- •diabetes mellitus or other metabolic diseases
- •pregnancy or breast feeding
结局指标
主要结局
blood sugar variation
时间窗: 4 weeks
measured by continuous blood glucose monitor
次要结局
未报告次要终点
