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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
Patients will be guided with a low GI diet with 60%\~70% of energy from carbohydrates. RCS constituted 30%\~50% of daily carbohydrate, and was supplemented as snacks every 4\~6 hours (25g per time) especially at night.
Peking Union Medical College Hospital
Beijing, China
RECRUITINGthe change of fasting blood glucose
the change of mean fasting blood glucose before and after nutritional intervention
Time frame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of requency of hypoglycemia onset
the change of requency of hypoglycemia onset before and after nutritional intervention
Time frame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of glycated albumin
the change of glycated albumin before and after nutritional intervention
Time frame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of satiety score
the change of self-reported satiety score before and after nutritional intervention. Satiety will be measured using a graphic rating scale that combined verbal descriptors on a scale graded 0-6 (0 = no sensation, 1 = just noticeable/threshold, 2 = very mild, 3 = mild, 4 = moderate, 5 = fullness, 6 = pain)
Time frame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of weight / BMI
the change of weight / BMI before and after nutritional intervention
Time frame: 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
the change of body fat mass (rate of fat mass) before and after nutritional intervention, through measurement by bioelectrical impedence analysis
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20
Time frame: 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
the change of total triglycerides, total cholesterol, LDL-C, HDL-C and free fatty acid befor and after nutritional intervention, through measurement by lipid profiles
Time frame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of uric acid
the change of uric acid before and after nutritional intervention
Time frame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery