Phase
Condition
Obesity
Diabetes And Hypertension
Diabetes Prevention
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
BMI ≥35 and ≤50 kg/m2
Diagnosis and treatment of T2DM at intake at bariatric ward with use of anti-diabeticmedication.
American Society of Anaesthesiologist Classification (ASA) ≤3
All patients are required to lose 6 kilograms of weight prior to surgery
Exclusion
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 herniarepair)
Auto-immune gastritis
Known presence of gastro-esophageal reflux disease
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
Primary lipid disorder
Participation in any other (therapeutic) study that may influence primary or secondaryoutcomes
Study Design
Study Description
Connect with a study center
medical Center Slotervaart
Amsterdam, Noord-Holland 1066EC
NetherlandsActive - Recruiting

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