The effects of the Laparoscopic Roux-en-Y Gastric Bypass and the Laparoscopic Mini Gastric Bypass on the remission of type 2 Diabetes Mellitus and the pathophysiological mechanisms that drive the conversion of malign to benign obesity

Recruiting

• Conditions: obesity; type 2 diabetes mellitus; 10018424; 10017943; 10019654

• Registration Number: NL-OMON50364
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

Age >=18 and <=65 years
BMI >=35 at the day of the intake on the bariatric ward and <=50 kg/m2 on the day
of surgery
Diagnosis and (starting of) treatment of T2DM at intake at bariatric ward with
anti-diabetic medication
American Society of Anaesthesiologist Classification (ASA) <=3
All patients are required to lose 6 kilograms of weight prior to surgery

Exclusion Criteria

Known genetic basis for insulin resistance or glucose intolerance
Type 1 DM
Prior Bariatric surgery
Patients requiring a concomitant intervention (such as cholecystectomy, ventral
hernia repair)
Auto-immune gastritis
Known presence of gastro-esophageal reflux disease confirmed by endoscopic
investigation or the use of proton-pump inhibitor indicated by complaints of
gastro-esophageal reflux (i.e. not indicated by polyfarmacia).
Known presence of large hiatal hernia requiring concomitant surgical repair
Coagulation disorders (PT time > 14 seconds, aPTT ((dependent on laboratory
methods) or known presence of bleeding disorders (anamnestic))
Known presence of hemoglobinopathy
Uncontrolled hypertension (RR > 150/95 mmHg)
Renal insufficiency (creatinine > 150 umol/L)
Pregnancy
Breastfeeding
Alcohol or drug dependency
Patients who are considered incapable to fully understand the study and
implications of participation in the study, as a consequence of a language
barrier, psychiatric disease or mental disabilities, as judged by the surgeon
or the coordinating researcher
Participation in any other (therapeutic) study that may influence primary or
secondary outcomes, Notably, patients that use vitamin K antagonists or
non-vitamin K antagonist oral anticoagulants (i.e. NOACs (Factor Xa
inhibitors)) and in whom peri-operative bridging with a therapeutic dose of
heparin is indicated, will not undergo intra-operative tissue and/or portal
vein sampling.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is to assess glycaemic control as measured by the<br /><br>difference in Hba1C at twelve months after LRYGB and LMGB.</p><br>