Application of Raw Corn Starch on Patients With Insulinoma

Not Applicable

• Conditions: Raw Corn Starch; Hyperinsulinemic Hypoglycemia; Insulinoma
• Interventions: Other: low GI diet with regular supplementation of raw corn starch

• Registration Number: NCT03930368
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-04-15
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-24
• Last Update Submitted: 2019-04-24
• Study First Posted: 2019-04-29
• Last Update Posted: 2019-04-29
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervened arm	low GI diet with regular supplementation of raw corn starch	as in a single-arm before-and after study, the only one arm will receive intervention of low GI diet with supplementation of RCS.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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 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 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 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
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China