Application of Raw Corn Starch on Patients With Insulinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes

NCT00691249

Hyperglycemia

COMPLETED NA

Food Containing Resistant Starch Type 4 and Postprandial Glycemic Response

NCT03844503

Healthy

COMPLETED NA

Effect of Resistant Starch Type 4 on Glycemia and Insulin Sensitivity in Young Adults

NCT00687960

Hyperglycemia

COMPLETED NA

Comparison of Different Types of Resistant Starch

NCT00930956

Postprandial Hyperglycemia

COMPLETED NA

Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance

NCT03658564

Insulin Resistance

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperinsulinemic Hypoglycemia Insulinoma Raw Corn Starch

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervened arm

as in a single-arm before-and after study, the only one arm will receive intervention of low GI diet with supplementation of RCS.

Group Type EXPERIMENTAL

low GI diet with regular supplementation of raw corn starch

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.