Application of Raw Corn Starch on Patients With Insulinoma

April 24, 2019 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change of fasting blood glucose
Time Frame: 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
from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of requency of hypoglycemia onset
Time Frame: 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
from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of glycated albumin
Time Frame: 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
from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change of satiety score
Time Frame: 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)
from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of weight / BMI
Time Frame: 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
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
Time Frame: 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
from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of lipid profile (level of total triglycerides, total cholesterol, LDL-C, HDL-C, free fatty acid ) before and after nutritional intervention
Time Frame: 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
from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of uric acid
Time Frame: 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
from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 24, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCS-insulinoma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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