Hyperinsulinemic Hypoglycemia, Insulinoma, Raw Corn Starch
Conditions
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.
Interventions
OTHERlow GI diet with regular supplementation of raw corn starch
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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change of fasting blood glucose | 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 |
| the change of requency of hypoglycemia onset | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| the change of satiety score | from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery | 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) |
| the change of uric acid | from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery | the change of uric acid before and after nutritional intervention |
| the change of weight / BMI | from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery | the change of weight / BMI before and after nutritional intervention |
| 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 body fat mass (rate of fat mass) before and after nutritional intervention, through measurement by bioelectrical impedence analysis |
Countries
China
Contacts
Primary ContactRongrong Li
Outcome results
None listed