Continuous Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery: The HypoSurge Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- • Difference between the two treatment arms in change in weekly diurnal time spent with hypoglycaemia (interstitial glucose <3.0 mmol/L) from the screening week to week 6, measured with a continuous glucose monitor.
研究概览
简要总结
The goal of this clinical trial is to learn if continuous glucose monitoring works to treat postprandial hypoglycaemia in patients who have undergone gastric bypass surgery. The main question it aims to answer is:
• Is continuous glucose monitoring superior to usual care for prevention of postprandial hypoglycaemia in patients with verified postprandial hypoglycaemia after gastric bypass surgery?
Researchers will compare continuous glucose monitoring to usual care to see if continuous glucose monitoring works to treat postprandial hypoglycaemia.
Participants will:
- Use a continuous glucose monitor for 6 weeks or use no continuous glucose monitor for 5 weeks and wear a blinded continuous glucose monitor for 1 week.
- Visit the clinic 2-3 times and have 2-3 phone consultations.
- Register symptoms of hypoglycaemia, answer questionnaires, undergo a 24-hour dietary recall interview conducted by a registered dietitian, measure weight and body composition and take blood samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Gastric bypass surgery at least 1 year ago
- •Age ≥18 years
- •Symptomatic postprandial hypoglycaemia; capillary glucose level <3.0 mmol/L 1-4 hours after meals
排除标准
- •Not able to give informed consent
- •Reduced compliance due to severe mental and psychiatric conditions
- •Use of insulin or sulfonylureas
- •Use of systemic corticosteroids
- •Primary or secondary adrenal insufficiency
- •Insulinoma
- •Severe heart-, lung, liver- or kidney disease, cancer, malnutrition and other medical conditions causing fragility
- •Performed bariatric revisional surgery
- •Drug- or alcohol abuse
- •Pregnancy
- •Use of acarbose or octreotide in the treatment of postprandial hypoglycemia
- •Use of continuous glucose monitor
结局指标
主要结局
• Difference between the two treatment arms in change in weekly diurnal time spent with hypoglycaemia (interstitial glucose <3.0 mmol/L) from the screening week to week 6, measured with a continuous glucose monitor.
时间窗: Screening (week 0) and week 6
Interstitial glucose is measured for one week during the screening week and for one week during week 6.
次要结局
- • Difference between the two treatment arms in change in weekly diurnal time spent with hypoglycaemia (interstitial glucose <3.9 mmol/L) from the screening week to week 6, measured with a continuous glucose monitor.(Screening (week 0) and week 6)
- • Difference between the two treatment arms in change in weekly time (total and nocturnal) spent with hypoglycaemia (interstitial glucose <3.0 mmol/L and <3.9 mmol/L) from the screening week to week 6, measured with a continuous glucose monitor.(Screening (week 0) and week 6)
- • Difference between the two treatment arms in change in weekly events (diurnal, total and nocturnal) of hypoglycaemia (interstitial glucose <3.0 mmol/L and <3.9 mmol/L) from the sceening week to week 6, measured with a continuous glucose monitor.(Screening (week 0) and week 6)
研究者
Heidi Borgeraas
Principal investigator
Sykehuset i Vestfold HF