Status:
UNKNOWN
The Effects of the Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Mini Gastric Bypass on the Remission of Type II Diabetes Mellitus
Lead Sponsor:
Slotervaart Hospital
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Obesity, Morbid
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
It is estimated that there will be 439-552 million people with type 2 diabetes mellitus (T2DM) globally in 2030. Type 2 Diabetes Mellitus is present in one quarter of patients at the bariatric outpati...
Detailed Description
Metabolic surgery has proven to be a viable long-term solution in the treatment of morbid obesity and its comorbidities. It induces rapid remission of type 2 diabetes mellitus (T2DM). Type 2 Diabetes ...
Eligibility Criteria
Inclusion
- BMI ≥35 and ≤50 kg/m2
- Diagnosis and treatment of T2DM at intake at bariatric ward with use of anti-diabetic medication.
- American Society of Anaesthesiologist Classification (ASA) ≤3
- All patients are required to lose 6 kilograms of weight prior to surgery
Exclusion
- 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
- 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 secondary outcomes
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03330756
Start Date
October 23 2017
End Date
November 1 2021
Last Update
November 9 2017
Active Locations (1)
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1
medical Center Slotervaart
Amsterdam, North Holland, Netherlands, 1066EC