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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051210200
Enrollment
30
Registered
2022-03-22
Start date
2022-05-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

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 form

Sponsors

Kubota Takeshi
Lead Sponsor
Otsuji Eigo
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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).

Design outcomes

Primary

MeasureTime frame
Frequency of hypoglycemia (less than 70mg/dl)

Secondary

MeasureTime frame
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.

Contacts

Public ContactTakeshi Kubota

University Hospital, Kyoto Prefectural University of Medicine

tkubot@koto.kpu-m.ac.jp+81-75-251-5527

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026