Application of Raw Corn Starch on Patients With Insulinoma

Insulinoma Clinical Trial

Official title:

Application of Raw Corn Starch on Patients With Unoperated Insulinoma is Helpful to Decrease Risk of Hypoglycemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03930368
• Other study ID #: RCS-insulinoma
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Peking Union Medical College Hospital
• Contact: Rongrong Li
• Phone: +8601069155550
• Email: lirongrong0331[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Hyperinsulinism
• Hyperinsulinemic Hypoglycemia
• Hypoglycemia
• Insulinoma
• Raw Corn Starch

Intervention

Other:
• low 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of fasting blood glucose	the change of mean fasting blood glucose before and after nutritional intervention	from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
Primary	the change of requency of hypoglycemia onset	the change of requency of hypoglycemia onset before and after nutritional intervention	from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
Primary	the change of glycated albumin	the change of glycated albumin before and after nutritional intervention	from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
Secondary	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)	from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
Secondary	the change of weight / BMI	the change of weight / BMI before and after nutritional intervention	from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
Secondary	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	from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
Secondary	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	from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
Secondary	the change of uric acid	the change of uric acid before and after nutritional intervention	from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery