Application of Raw Corn Starch on Patients With Unoperated Insulinoma is Helpful to Decrease Risk of Hypoglycemia
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- the change of requency of hypoglycemia onset
研究概览
简要总结
This will be a prospective single-arm before-and-after clinical trial in which raw corn starch (RCS) will be first applied on patients with unoperated insulinoma. Nutritional intervention with supplementation of RCS will be initiated in 20 patients with suspected insulinoma to improve their hypoglycemia before the surgery. Duration of nutritional intervention, fasting blood glucose, lipid profile, weight change, BMI and other metabolic indices will be recorded and compared before and after the intervention.
详细描述
Insulinoma is a rare disease which can cause recurrent hyperinsulinemic hypoglycemia, subsequent hyperphagia as well as weight gain. As only 50% ~ 60% of pharmacological therapy (diazoxide, somatostatin, etc) is effective to elevate blood glucose, the nutritional interventions play a role as an important supportive treatment to maintain glycemic stablization and control weight gain before the curative surgery. As the essential management for patients with glycogen storage disease (GSD), the extended release cornstarch has been proved superior to prevent hypoglycemia since 1980s. Its application has elevated GSD patients' quality of life and prolonged their survival. In view of its charicteristic of chronic release in gastrointestinal tract, we will for the first time try to utilize the raw corn starch (RCS) on patients with suspected insulinoma and evaluate its efficacy of improving hypoglycemia in such patients.
This will be a prospective single-arm before-and-after clinical trial. Nutritional intervention with supplementation of RCS will be initiated in 20 patients with suspected insulinoma to improve their hypoglycemia before the surgery. Duration of nutritional intervention, fasting blood glucose, lipid profile, weight change, BMI and other metabolic indices will be recorded and compared before and after the intervention.
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
- •having recurrent symptoms of hypoglycemia (blood glucose less than 2.8 mmol/L) which could be relieved by intake of glucose, which condition accords with typical Whipple triad.
- •being proved to have abnormally increased secretion of endogeneous insulin at onset of hypoglycemia.
- •diagnosis of insulinoma is highly suspected, in view of clinical presentation, laboratory tests and imaging examinations.
排除标准
- •severe gastrointestinal dysfunction with intolerance of raw corn starch
研究组 & 干预措施
Intervened arm
as in a single-arm before-and after study, the only one arm will receive intervention of low GI diet with supplementation of RCS.
干预措施: low GI diet with regular supplementation of raw corn starch (Other)
结局指标
主要结局
the change of requency of hypoglycemia onset
时间窗: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of requency of hypoglycemia onset before and after nutritional intervention
the change of glycated albumin
时间窗: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of glycated albumin before and after nutritional intervention
the change of fasting blood glucose
时间窗: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of mean fasting blood glucose before and after nutritional intervention
次要结局
- the change of satiety score(from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery)
- the change of weight / BMI(from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery)
- the change of uric acid(from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery)
- the change of body fat mass (rate of fat mass) before and after nutritional intervention(from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery)
- the change of lipid profile (level of total triglycerides, total cholesterol, LDL-C, HDL-C, free fatty acid ) before and after nutritional intervention(from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery)