Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT03330756
Eligibility Criteria:
Inclusion Criteria:
* 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 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
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03330756
Study Brief:
Protocol Section:
NCT03330756