JRCT ID: jRCTs051210200
Registered date:22/03/2022
Effectiveness of the enteral low-carbohydrate formula on post-gastrectomy hypoglycemia
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | gastric cancer |
Date of first enrollment | 26/05/2022 |
Target sample size | 30 |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | Frequency of hypoglycemia (less than 70mg/dl) |
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Secondary Outcome | 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. |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 80age old |
Gender | Both |
Include criteria | 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. |
Exclude criteria | 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). |
Related Information
Primary Sponsor | Kubota Takeshi |
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Secondary Sponsor | Otsuji Eigo |
Source(s) of Monetary Support | |
Secondary ID(s) |
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 |
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 |
tkubot@koto.kpu-m.ac.jp | |
Affiliation | University Hospital, Kyoto Prefectural University of Medicine |