A Trial of the Jejunal to Ileal Diversion Endoscopic Procedure (Side-to-Side Anastomosis)

GI Windows

Status

Completed

Conditions

Diabetes

Treatments

Device: Jejunal to Ileal Diversion

Study type

Interventional

Funder types

Industry

Identifiers

NCT02839512

GIW 14-001

Details and patient eligibility

About

This is a single center study to assess metabolic effects in subjects after a Jejunal to Ileal Diversion procedure was performed using colonoscopes.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)