Clinical trial NCT02839512: A Trial of the Jejunal to Ileal Diversion Endoscopic Procedure (Side-to-Side Anastomosis)
Official title: A Trial of the Jejunal to Ileal Diversion Endoscopic Procedure (Side-to-Side Anastomosis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: GI Windows, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in glycosylated hemoglobin A1c
timeFrame: 12 months
Secondary outcomes:
measure: Weight loss (%TBWL)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Ostrava Hospital
name: Evžen Machytka
role: PRINCIPAL_INVESTIGATOR
References:
citation: Machytka E, Buzga M, Zonca P, Lautz DB, Ryou M, Simonson DC, Thompson CC. Partial jejunal diversion using an incisionless magnetic anastomosis system: 1-year interim results in patients with obesity and diabetes. Gastrointest Endosc. 2017 Nov;86(5):904-912. doi: 10.1016/j.gie.2017.07.009. Epub 2017 Jul 14.