Diabetes Mellitus type 2 (DM type II), Obesity, suikerziekte, overgewicht, obesitas.
Conditions
Interventions
1. Roux-en-Y Gastric bypass (RYGB)
2. Conventional treatment arm: standard of care according to the Dutch Guidelines of General practitioners (NHG standard).
Sponsors
Leiden University Medical Center (LUMC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed consent; 2. Age 18-60 years (current criteria, age can be expanded if patient is in good condition but with a limit to 70 years); 3. DM2; 4. Fasting plasma c-peptide > 0.8 ng/ml; 5. HbA1c > 7.0% despite diet/lifestyle advises and 2 glucose-lowering drugs with the exception of insulin; 6. BMI> 35 kg/m2 and <45 kg/m2; 7. Has attempted to lose weight without (lasting) success.
Exclusion criteria
Exclusion criteria: 1. Use of insulin; 2. Substance abuse/dependence; 3. Mentally instable/psychiatric disorder (according to evaluation psychologist); 4. Some eating disorders; 5. Physical condition not good enough to sustain operation: IFSO and ASA criteria; 6. No diabetes type 2; 7. Fasting plasma c-peptide < 0.8 ng/ml; 8. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. HbA1c difference of 1% (or 11 mmol/mol; SD 1.5% or 16.5 mmol/mol); 2. Achievement of HbA1c target of < 7% (< 53 mmol/mol); 3. Remission of DM2 defined as FPG < 7.0 mmol/L and HbA1c < 6.5% (<48 mmol/mol). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life (EQ5D); 2. Body weight; 3. Cardiovascular risk factors (total cholesterol, HDL-cholesterol, triglycerides, LDL-cholesterol, systolic and diastolic blood pressure, waist circumference, 10-year cardiovascular risk estimates according to the United Kingdom Prospective Diabetes study (UKPDS) risk engine; 4. Use of medication for diabetes, dyslipidemia and blood pressure; 5. Microalbuminuria (urinary albumin/creatinin ratio > 2.5 g/mol for men and > 3.5 g/mol for women). | — |
Contacts
Public ContactM.A. Sleddering
Postbus 9600
Outcome results
None listed