DiabetesNCT02839512
A Trial of the Jejunal to Ileal Diversion Endoscopic Procedure (Side-to-Side Anastomosis)
A study testing Jejunal to Ileal Diversion in people with Diabetes, run by GI Windows, Inc..
Trial summary
This is a single center study to assess metabolic effects in subjects after a Jejunal to Ileal Diversion procedure was performed using colonoscopes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Jejunal to Ileal Diversion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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)
About this study
This is a single center study to assess metabolic effects in subjects after a Jejunal to Ileal Diversion procedure was performed using colonoscopes.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Jejunal to Ileal Diversion
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jejunal to Ileal DiversionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Jejunal to Ileal Diversion | Experimental | All subjects who receive jejunal to ileal diversion endoscopic procedure Receives: Device: Jejunal to Ileal Diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycosylated hemoglobin A1c
Difference from baseline HbA1c at baseline and HbA1c at 12 months
Measured: 12 months
Secondary outcomes (1)
Weight loss (%TBWL)
Difference from baseline total body weight loss at baseline and total body weight loss at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startOct 2014
- Primary completionApr 2016
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- GI Windows, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Evžen Machytka, Principal investigator, University of Ostrava Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839512
- Sponsor's protocol ID
- GIW 14-001
- Status last verified
- Jul 2020
- First submitted
- 11 Jul 2016
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 12 Month Study results published in Gastrointestinal Endoscopy in 2017
Publications
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.
PubMed 28716404
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of the Jejunal to Ileal Diversion Endoscopic Procedure (Side-to-Side Anastomosis)
- ClinicalTrials.gov ID
- NCT02839512
- Acronym / sponsor ID
- GIW 14-001
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GI Windows, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jejunal to Ileal Diversion | Experimental | Device: Jejunal to Ileal DiversionAll subjects who receive jejunal to ileal diversion endoscopic procedure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jejunal to Ileal DiversionThe 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. | Device | Jejunal to Ileal Diversion |
Primary outcome
Change in glycosylated hemoglobin A1c
Time frame: 12 months
Difference from baseline HbA1c at baseline and HbA1c at 12 months
1 secondary outcome
Weight loss (%TBWL)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Results publication: PubMed 28716404Machytka 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.
- Individual participant dataSharing planned: No. 12 Month Study results published in Gastrointestinal Endoscopy in 2017
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evžen Machytka principal investigator
University of Ostrava Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Jejunal to Ileal Diversion in people with Diabetes, run by GI Windows, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycosylated hemoglobin A1c (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02839512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.