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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051210200

Registered date:22/03/2022

Effectiveness of the enteral low-carbohydrate formula on post-gastrectomy hypoglycemia

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedgastric cancer
Date of first enrollment26/05/2022
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)arm A, Oral adminisration of the enteral low-carbohydrate formula (400ml/day) in the first half 1 week during 2 weeks glucose monitoring. arm B, Oral adminisration of the enteral low-carbohydrate formula (400ml/day) in the second half 1 week during 2 weeks glucose monitoring.

Outcome(s)

Primary OutcomeFrequency of hypoglycemia (less than 70mg/dl)
Secondary OutcomeGlycemic 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.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
Include criteria1)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.
Exclude criteria1) 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).

Related Information

Contact

Public contact
Name Takeshi Kubota
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto city, Kyoto Prefecture Kyoto Japan 602-8566
Telephone +81-75-251-5527
E-mail tkubot@koto.kpu-m.ac.jp
Affiliation University Hospital, Kyoto Prefectural University of Medicine
Scientific contact
Name Takeshi Kubota
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto city, Kyoto Prefecture Kyoto Japan 602-8566
Telephone +81-75-251-5527
E-mail tkubot@koto.kpu-m.ac.jp
Affiliation University Hospital, Kyoto Prefectural University of Medicine