Efficacy in DIabetes treatment: Surgery Or coNventional: the EDISON-trial.
Recruiting
- Conditions
- Diabetes Mellitus type 2 (DM type II), Obesity, suikerziekte, overgewicht, obesitas.
- Registration Number
- NL-OMON20371
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
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);
Exclusion Criteria
1. Use of insulin;
2. Substance abuse/dependence;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. HbA1c difference of 1% (or 11 mmol/mol; SD 1.5% or 16.5 mmol/mol);<br /><br>2. Achievement of HbA1c target of < 7% (< 53 mmol/mol);<br /><br>3. Remission of DM2 defined as FPG < 7.0 mmol/L and HbA1c < 6.5% (<48 mmol/mol).
- Secondary Outcome Measures
Name Time Method 1. Quality of life (EQ5D);<br /><br>2. Body weight;<br /><br>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;<br /><br>4. Use of medication for diabetes, dyslipidemia and blood pressure;<br /><br>5. Microalbuminuria (urinary albumin/creatinin ratio > 2.5 g/mol for men and > 3.5 g/mol for women).