diabetes
Conditions
Interventions
BMI<28group:gastric bypass
BMI=28 group:gastric bypass
Sponsors
General Hospital of Guangzhou Military Command of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Because of poor HbAlc control in Chinese patients with low BMIs and T2DM after standard LRYGB surgery (supplemental table 1 and 2), we attempted to modify the standard LRYGB surgery. This study and the described technology were conducted in compliance with a protocol approved by the Ethics Committee of General Hospital of Guangzhou Military Command of PLA; this study was also registered with ClinicalTrials.gov (ID: NCT02091323). Written informed consent regarding this research and surgical operations were obtained from all participants and their families prior to surgery. Patient enrollment in this study did not affect the treatment standard of care. All patients were diagnosed with DM according to criteria in the Standards of Medical Care in Diabetes-2014. The diagnostic criteria are as follows: in a patient with classic symptoms of hyperglycemia or a hyperglycemic crisis, DM is indicated by a random plasma glucose (PG) more than 11.1 mmol/L (200 mg/dL) or a fasting plasma glucose (FPG) more than 7.0 mmol/L (126 mg/dL); a 2-hour PG more than 11.1 mmol/L (200 mg/dL) during an oral glucose tolerance test (OGTT) or HbA1c >6.5% is also diagnostic. The results were confirmed by repeated testing, and patients were diagnosed with DM if any of the above criteria were met. Additionally, candidates were included if they met the following criteria: 1. absence of T1DM; 2. waist circumference >90 cm for men and >80 cm for women; 3. T2DM duration <15 years; 4. age younger than 65 years; ? islet functional reserve parameters such as a fasting C-peptide (FC-P) at a normal or higher level and postprandial 2-hour C-peptide response more than twice the fasting response; ? medication-uncontrolled DM and HbA1c =7.0%; and ? agreement to undergo LRYGB surgery with provision of signed consent.
Exclusion criteria
Exclusion criteria: (1) drug abuse, alcohol addiction, patients with uncontrolled mental illness as well as routine medical risks, benefits, expected consequences of the lack of ability to understand the patient; (2) poor general condition, surgery is not possible; (3) a clear diagnosis of type 1 diabetes; (4) those with poor patient compliance; (5) gestational diabetes and other special types of diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fasting glucose;Glycosylated hemoglobin; | — |
Countries
China
Contacts
Public ContactWu Liangping
Outcome results
None listed