Efficacy of Laparoscopic Roux-en-Y Gastric Bypass Surgery versus Conventional Therapy for Type 2 Diabetes Mellitus in Moderate Obese Patients with BMI of 30 -35 kg/m2: a randomized controlled trial.

Withdrawn

Conditions: Obesitas
Obesity
overweight
10018424
10017998

Registration Number: NL-OMON40441

Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1. Informed consent
2. Age 18 * 50 years
3. BMI 30-35 kg/m2
4. Medical history of DM2
a. Metformin + (SU-derivate/DPP4-remmer)
b. Insulin dependent; with or without oral diabetic medication
c. GLP-1 analogue; with or without oral diabetic medication
5. HbA1c > 7.0% and Fasting Plasma Glucose (FPG) > 7.9 mmol/L

Exclusion Criteria

1. No diabetes
2. History of bariatric surgery
3. C-peptide <0,27nmol/L
4. Enable to follow medical advises: language barrier, genetic disorders
5. Obesity due to medical disorder (e.g. Cushing syndrome)
6. Contra-indication for RYGB surgery: inflammatory bowel disease (Morbus Crohn / Colitis Ulcera)
7. Renal failure (MDRD < 30)
8. Pregnancy
9. Psychiatric disorder

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Complete remission of DM2 defined as FPG < 5.6 mmol/L and HbA1c < 6.0% (<42<br /><br>mmol/mol) without anti-diabetic medication for minimal 1 year </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Improvement of HbA1c: HbA1c difference of 1% (or 11 mmol/mol; SD 1.5% or 16.5<br /><br>mmol/mol), and Achievement of HbA1c target of < 7% (< 53 mmol/mol). Body weight<br /><br>loss: defined as (loss of) absolute body weight, Total Body Weight Loss<br /><br>(%TBWL), Excess BMI loss (%EBL), excess weight loss (%EWL); Quality of life;<br /><br>SF-36 questionnaire, BAROS (Bariatric Analysis and Reporting Outcome System)<br /><br>score; Cardiovascular risk factors and 10-year cardiovascular risk estimates<br /><br>according to the United Kingdom Prospective Diabetes study risk engine;<br /><br>Microalbuminuria (urinary albumin/creatinin ratio > 2.5 g/mol for men and > 3.5<br /><br>g/mol for women); surgical complication rate: such as anastomotic leakage,<br /><br>bleeding, wound infection, trombo-embolic events, internal hernia; vitamin<br /><br>deficiencies: vitamin D, vitamin B12, folate. </p><br>