Diabetes
Conditions
Brief summary
This is a single center study to assess metabolic effects in subjects after a Jejunal to Ileal Diversion procedure was performed using colonoscopes.
Detailed description
The Jejunal to Ileal Diversion procedure is an adaptation of a biliopancreatic diversion with duodenal switch, which is a surgical procedure used to treat metabolic syndrome conditions. The small bowel diversion of the jejunum into the ileum by creating a single anastomosis just beyond the ligament of Trietz will be studied. Up to 15 eligible subjects will be enrolled into the trial. Enrollment will stop once 10 subjects have undergone the Jejunal to Ileal Diversion procedure.
Interventions
DEVICEJejunal to Ileal Diversion
The Jejunal to Ileal Diversion procedure will be performed using colonoscopes to place magnets to create a side to side compression anastomosis. The colonoscope delivered magnet creates the proximal end of the anastomosis approximately 100 cm distal from the ligament of Treitz. The colonoscope delivered magnets creates the distal end of the anastomosis approximately 100 cm proximal from the ileocecal junction.
Sponsors
GI Windows, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 65 years of age * A BMI ≥ 30 kg/m2 and \< 50 kg/m2 If subject has Type 2 Diabetes * HbA1c ≥ 6.5% and ≤ 9% * Fasting plasma glucose greater than 110 mg/dl * Treatment with up to 2 oral diabetic medications * Able to understand and sign informed consent document * If subject is female, she must commit to not becoming pregnant for 18 months and agree to use of contraceptives during this period
Exclusion criteria
* Any conditions for which endoscopy/colonoscopy would be contraindicated. * Congenital or acquired anomalies of the GI tract, including atresias, stenosis or malrotation. * Previous abdomino-pelvic surgery that may result in adhesions or anatomical changes that may interfere with placement of the GIW device. * Diagnosis of Type 2 diabetes less than 6 months * More than 2 oral diabetic medications * Use of insulin * If on metformin, history of polycystic ovarian syndrome (PCOS) * Use of Dipeptidyl peptidase-4 (DPP-4) inhibitors * Use of GLP-1 agonists * Use of Use of alpha-glucosidase inhibitors * Type 1 Diabetes * Unable or unwilling to perform home blood glucose monitoring * History of or suspected gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease) * History of active malignancy (i.e. not in remission) with the exception of squamous or basal cell carcinoma of the skin * Any blood coagulation disorder * Implanted cardiac pacemaker, defibrillator or other implanted electric device - Ongoing systemic infection * Chronic pancreatitis * Chronic liver disease of any cause * Poorly controlled psychiatric disease (e.g. ongoing major depression, schizophrenia, borderline personality, suicidality, psychosis) * Any history of an eating disorder within the past 5 years * Pre-existing severe comorbid cardio-respiratory disease (e.g. congestive heart failure, cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease, pulmonary embolism) * Uncontrolled hypertension (systolic BP \> 150 mm Hg or diastolic BP \> 100 mm Hg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycosylated hemoglobin A1c | 12 months | Difference from baseline HbA1c at baseline and HbA1c at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss (%TBWL) | 12 months | Difference from baseline total body weight loss at baseline and total body weight loss at 12 months |
Outcome results
None listed