Hyperinsulinemic HypoglycemiaNCT03930368
Application of Raw Corn Starch on Patients With Insulinoma
A study testing low GI diet with regular supplementation of raw corn starch in people with Hyperinsulinemic Hypoglycemia and Insulinoma, run by Peking Union Medical College Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperinsulinemic Hypoglycemia, Insulinoma, Raw Corn Starch
- What is being tested?
- low GI diet with regular supplementation of raw corn starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- severe gastrointestinal dysfunction with intolerance of raw corn starch
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Rongrong Li, +8601069155550, lirongrong0331@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperinsulinemic Hypoglycemia, Insulinoma, Raw Corn Starch
- Being tested
- low GI diet with regular supplementation of raw corn starch
- Medical subject headings
- Congenital Hyperinsulinism, Insulinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low GI diet with regular supplementation of raw corn starchOther
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 group | Role | What they receive |
|---|---|---|
| Intervened arm | Experimental | as in a single-arm before-and after study, the only one arm will receive intervention of low GI diet with supplementation of RCS. Receives: Other: low GI diet with regular supplementation of raw corn starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of fasting blood glucose
the change of mean fasting blood glucose before and after nutritional intervention
Measured: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of requency of hypoglycemia onset
the change of requency of hypoglycemia onset before and after nutritional intervention
Measured: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of glycated albumin
the change of glycated albumin before and after nutritional intervention
Measured: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
Secondary outcomes (5)
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)
Measured: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of weight / BMI
the change of weight / BMI before and after nutritional intervention
Measured: 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
the change of body fat mass (rate of fat mass) before and after nutritional intervention, through measurement by bioelectrical impedence analysis
Measured: 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
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
Measured: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
the change of uric acid
the change of uric acid before and after nutritional intervention
Measured: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start15 Apr 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperinsulinemic HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930368
- Sponsor's protocol ID
- RCS-insulinoma
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Raw Corn Starch on Patients With Unoperated Insulinoma is Helpful to Decrease Risk of Hypoglycemia
- ClinicalTrials.gov ID
- NCT03930368
- Acronym / sponsor ID
- RCS-insulinoma
- Conditions
- Hyperinsulinemic Hypoglycemia, Insulinoma, Raw Corn Starch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervened arm | Experimental | Other: low GI diet with regular supplementation of raw corn starchas in a single-arm before-and after study, the only one arm will receive intervention of low GI diet with supplementation of RCS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- severe gastrointestinal dysfunction with intolerance of raw corn starch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low GI diet with regular supplementation of raw corn starchPatients 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. | Other | Intervened arm |
Primary outcome
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
5 secondary outcomes
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 weight / BMI
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
Time frame: 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 uric acid
Time frame: from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low GI diet with regular supplementation of raw corn starch in people with Hyperinsulinemic Hypoglycemia and Insulinoma, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongrong Li (+8601069155550, lirongrong0331@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.