Clinical trial NCT03930368: Application of Raw Corn Starch on Patients With Insulinoma
Official title: Application of Raw Corn Starch on Patients With Unoperated Insulinoma is Helpful to Decrease Risk of Hypoglycemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperinsulinemic Hypoglycemia
Insulinoma
Raw Corn Starch
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In vie of the fact that insulinoma is a rare disease and it will be difficult to enroll enough cases in this study, a prospective single-arm before-and-after study will be performed.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* severe gastrointestinal dysfunction with intolerance of raw corn starch

Primary outcomes:
measure: the change of fasting blood glucose
timeFrame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
measure: the change of requency of hypoglycemia onset
timeFrame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
measure: the change of glycated albumin
timeFrame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
Secondary outcomes:
measure: the change of satiety score
timeFrame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
measure: the change of weight / BMI
timeFrame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
measure: the change of body fat mass (rate of fat mass) before and after nutritional intervention
timeFrame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
measure: the change of lipid profile (level of total triglycerides, total cholesterol, LDL-C, HDL-C, free fatty acid ) before and after nutritional intervention
timeFrame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
measure: the change of uric acid
timeFrame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References: