At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes mellitus diagnosis
- ✓BMI 30-49 kg/m²
- ✓HbA1c ≥6.5% (48 mmol/mol)
- ✓Prior lifestyle intervention attempted for ≥6 months without adequate weight loss
- ✕Type 1 diabetes or MODY
- ✕Secondary diabetes from specific disease or glucocorticoid therapy
- ✕History of bariatric or complex abdominal surgery
- ✕Inflammatory bowel disease, pancreatitis, or active cholelithiasis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
EndoBarrierTM in Obese Subjects With Type 2 Diabetes: Impact on Pancreatic Function, Insulin Resistance, Gut Peptides and Gut Permeability - a Pilot Study
In Brief
A clinical study evaluating EndoBarrier for Type 2 Diabetes and Obesity. Completed, enrolled 10 participants across 1 site.
Detailed Summary
The aim of the study is to explore short and longer-term effects of the Endobarrier™ implantation on insulin resistance and beta-cell function assessed by repeated Botnia clamps. In addition changes in gut peptides and gut permeability after implantation of a removable duodeno-jejunal bypass device to induce diabetes remission in obese subjects with sub-optimally controlled type 2 diabetes mellitus will be determined. Further changes in body weight and body composition, the change in global cardiovascular risk from baseline to 12 months, estimated using the UKPDS risk engine will be recorded.
Study Details
Timeline
Interventions
implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus