Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes
Verified date | August 2020 |
Source | Kyungpook National University Chilgok Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
There is a rapidly growing interest in metabolic surgery for the treatment of type 2
diabetes. However, its efficacy in the non-morbidly population is not clear yet and the
underlying mechanism remains elusive.
Meanwhile, the incidence of early gastric cancer (EGC) in Korea has gradually increased, the
long-term quality of life of the patients with EGC has become an important issue. Since the
reconstruction methods after gastric cancer surgery are similar to that of metabolic surgery,
some surgeons have attempted to modify the reconstruction methods after standard radical
gastrectomy to achieve better glycemic control in gastric cancer patients with type 2
diabetes.
The present study aimed to investigate the changes in glucose metabolism and incretin hormone
responses following different types of reconstruction after distal gastrectomy in
non-morbidly obese gastric cancer patients with type 2 diabetes. This is a non-randomized,
prospective, single-center, phase II pilot study.
Patients diagnosed with stage I gastric cancer and type 2 diabetes are eligible for the
present study. Patients who will undergo laparoscopic distal gastrectomy for cancer located
at the lower two-thirds of the stomach will only be included. The reconstruction method will
be selected among conventional Billroth I, long-limb Billroth II (with 100 cm-long
biliopancreatic limb), or long-limb Roux-en-Y (with 100 cm-long Roux limb) reconstruction
methods according to the surgeon's preference as well as the size of the remnant stomach. All
the patients are subjected to a 75g-oral glucose tolerance test (OGTT) preoperatively, and at
5 days, 3 months, 6 months postoperatively and serum glucose, as well as incretin hormones,
will be serially measured.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 31, 2019 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients diagnosed with type 2 diabetes as well as pathologically proven gastric cancer of clinical stage I according to the AJCC 7th edition - Those who are expected to undergo laparoscopic distal gastrectomy - Body mass index < 30 kg/m2 Exclusion Criteria: 1. baseline fasting C-peptide level < 1.0 ng/dL (who had the possibility of type 1 diabetes) 2. previous radiotherapy or surgery at upper abdomen other than laparoscopic cholecystectomy 3. other malignancies in recent 5 years 4. vulnerable patients (pregnant women, those with cognitive impairment, etc) 5. ECOG-PS = 2 6. participating in other clinical trials within 6 months |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyungpook National University Chilgok Hospital | Daegu |
Lead Sponsor | Collaborator |
---|---|
Kyungpook National University Chilgok Hospital | Kyungpook National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diabetes remission rate | the rate of patients achieving HbA1c < 6.5% without antidiabetic medications | at 6 months after surgery |
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