Application of Raw Corn Starch on Patients With Insulinoma

NCT03930368 | Unknown

• 1 other identifier: RCS-insulinoma
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperinsulinemic Hypoglycemia; Insulinoma; Raw Corn Starch

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• the change of satiety score

  from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery

• the change of weight / BMI

  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

  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

  from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery

• the change of uric acid

  from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery

Study Arms (1)

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.

Other: low GI diet with regular supplementation of raw corn starch

Interventions

low GI diet with regular supplementation of raw corn starch 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.

Intervened arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• severe gastrointestinal dysfunction with intolerance of raw corn starch

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Congenital Hyperinsulinism; Insulinoma

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypoglycemia; Adenoma, Islet Cell; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Endocrine System Diseases

Central Study Contacts

Rongrong Li

CONTACT

+8601069155550; lirongrong0331@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 29, 2019
• Study Start: April 15, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)