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临床试验/NCT05011682
NCT05011682已完成不适用

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

Helse Nord-Trøndelag HF1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2021年8月27日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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