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出境医 / 临床实验 / Application of Raw Corn Starch on Patients With Insulinoma

Application of Raw Corn Starch on Patients With Insulinoma

Study Description
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.

Condition or disease Intervention/treatment Phase
Hyperinsulinemic Hypoglycemia Insulinoma Raw Corn Starch Other: low GI diet with regular supplementation of raw corn starch Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of Raw Corn Starch on Patients With Unoperated Insulinoma is Helpful to Decrease Risk of Hypoglycemia
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Rongrong Li +8601069155550 lirongrong0331@163.com

Locations
Layout table for location information
China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Rongrong Li    +8601069155550    lirongrong0331@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date April 29, 2019
Actual Study Start Date  ICMJE April 15, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • 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)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Application of Raw Corn Starch on Patients With Insulinoma
Official Title  ICMJE Application of Raw Corn Starch on Patients With Unoperated Insulinoma is Helpful to Decrease Risk of Hypoglycemia
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperinsulinemic Hypoglycemia
  • Insulinoma
  • Raw Corn Starch
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: low GI diet with regular supplementation of raw corn starch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 24, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03930368
Other Study ID Numbers  ICMJE RCS-insulinoma
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking Union Medical College Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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