Diabetes
Conditions
Brief summary
The purpose of this study is to investigate the role of an experimental surgery that may offer better short and long-term control of T2DM in select patients who have not achieved adequate blood sugar control with regular means.
Interventions
PROCEDUREDuodenal Exclusion
duodenal-jejunal bypass
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age between 20 and 50 years old; * BMI between 27 and 34.9; * Oral agents or insulin to control T2DM; * Inadequate control of diabetes as defined as HbA1c\>8.0% but \<10% * Understanding of the mechanisms of action of the treatment
Exclusion criteria
* More than 5 years of T2DM diagnosis; * C-peptide \<1pg/ml (off insulin) * Previous abdominal operations; * History of gastritis * History of GERD * History of peptic ulcer disease * Inflammatory bowel disease * Coagulopathy; * Liver cirrhosis; * Unable to comply with study requirements, follow-up schedule or give valid informed consent; * Currently pregnant (pregnancy test required for confirmation for those of child bearing years) * Patient is not available for programmed follow-up during the study period * Patient is unwilling to forgo good samaritan blood donation during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success based on patients' glycemic control | 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| Physiologic Measurements, Comorbidity improvement, Improvement in QOL | 12 Months |
Outcome results
None listed