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2019-04-15
2019-12
2019-12
20
NCT03930368
Peking Union Medical College Hospital
Peking Union Medical College Hospital
INTERVENTIONAL
Application of Raw Corn Starch on Patients With Insulinoma
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-04-16 | N/A | 2019-04-24 |
2019-04-24 | N/A | 2019-04-29 |
2019-04-29 | N/A | 2019-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Rongrong Li Phone Number: +8601069155550 Email: lirongrong0331@163.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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