Effectiveness of the enteral low-carbohydrate formula on post-gastrectomy hypoglycemia
- Conditions
- gastric cancer
- Registration Number
- JPRN-jRCTs051210200
- Lead Sponsor
- Kubota Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
1)Patients who have obtained written informed consent for participation in the research.
2)Men and women aged 20 to 80 at the time of informed consent acquisition.
3)Patients who had been diagnosed with gastric cancer and 1-5 years have passed since they underwent gastrectomy (total gastrectomy and distal gastrectomy).
4)Patients who have stable daily food intake and independent feeding behavior.
5)Patients who understand the purpose of this study and can take the enteral low-carbohydrate formula by self-regulation.
1) Patients who have a history of abdominal surgery within 3 months.
2)Patients who take the other nutritional supplement.
3)Patients with galactosemia.
4)Patients who have a history of hypersensitivity or diarrhea to the enteral low-carbohydrate formula.
5)Patients who are being treated with insulin injections for type-1 or type-2 diabetes.
6)Patients with poor glycemic control (HbA1c is 6.5% or higher, and/or casual blood glucose is 200mg/dL or higher).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of hypoglycemia (less than 70mg/dl)
- Secondary Outcome Measures
Name Time Method Glycemic variability (Standard deviation of glycemic concentration), Frequency of hyperglycemia (more than 180mg/dl), Nocturnal hypoglycemia (Frequency of BS less than 70mg/dl during 0:00-06:00), Hypoglycemic symptom (Evaluate using the PGSAS-37 questionnaire), Compliance of the intake of the enteral low-carbohydrate formula, QOL.