DiabetesNCT02283632
A Trial of the Jejunal Diversion Procedure
A study testing Jejunal Diversion in people with Diabetes and Obesity, run by Ethicon Endo-Surgery at 1 site in Czechia.
Trial summary
This is a single site trial to assess metabolic effects in subjects after a Jejunal Diversion procedure was performed. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- What is being tested?
- Jejunal Diversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCzechia
- Study dates
- Oct 2014to May 2016
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 20 to 60 years of age (inclusive) on the date the ICD is signed
- A BMI ≥ 27 kg/m2 and < 40 kg/m2
- HbA1c ≥ 8% (63.9 mmol/mol) and ≤ 11% (96.7 mmol/mol)
- C-peptide ≥ 3 ng/mL (0.999 nmol/L)
- At least one of the following:
- Systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg, or on anti-hypertensive medication
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- HDL < 40 mg/dL (1.0344 mmol/L) (men) or < 50 mg/dL (1.293 mmol/L) (women), or on medication for low HDL
- LDL > 100 mg/dL (2.586 mmol/L), or on medication for high LDL
- TG ≥ 150 mg/dL (1.694 mmol/L) or on TG lowering medication treatment
- FPG ≥ 100 mg/dL (5.556 mmol/L) or on medication for hyperglycemia or anti-T2DM
- Able to comprehend and sign the EC-approved trial ICD
Who cannot join
- Unable or unwilling to attend follow-up visits and examinations
- History of drug and/or alcohol abuse within 2 years of Screening Visit
- Any previous major GI surgery (e.g., any GI surgery with a resection, etc.) Examples of previous GI surgery allowed include: appendectomy, gall bladder surgery, liver biopsies, endoscopic procedures, etc.
- Scheduled concurrent surgical procedure
- Women of childbearing potential who are pregnant or lactating at the time of screening, at the time of surgery, or planning to become pregnant during the follow-up period
- Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression, or history of suicide attempts
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- Any condition which precludes compliance with the trial, including:
- Inflammatory diseases of the GI tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis that have been active within the past 10 years
- History of Hepatitis B or C
- T1DM
- LADA (confirmed by positive GAD autoantibodies, IAA, and ICA)
- Immunocompromised such as that resulting from chronic oral steroid use, cancer chemotherapeutic agents, or immune deficiency disorders
- Screening laboratory tests with any of the following:
- ALT and/or AST levels ≥ 4 times ULN according to laboratory normal ranges
- Blood creatinine level ≥ 1.5 times ULN according to laboratory normal ranges
- BUN level ≥ 1.5 times ULN according to laboratory normal ranges
- Use of any of the following medications in the past 120 days:
- Chronic steroid use
- Prescription or over-the-counter medications or supplements with a primary indication known to cause or assist in weight reduction
- Use of any of the following medications in the past 60 days:
- Promotility agents
- Any other medical condition or finding for which, at the discretion of the PI, the subject should be excluded
- Participation in any other clinical trial (not to include registries or survey-only studies) within 30 days or 5 half lives of an investigational drug (which ever is longer), of Visit 1 (Screening Visit) and for the duration of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial of the Jejunal Diversion Procedure (Side-to-side Jejuno-jejunostomy) (Europe)
This is a single site trial to assess metabolic effects in subjects after a Jejunal Diversion procedure was performed.
Read the detailed description
The Jejunal Diversion procedure is an adaptation of a jejuno-jejunostomy, which is a surgical procedure often used to address a mix of pathological conditions. The safety of the Jejunal Diversion procedure is not in question, but rather understanding the gastrointestinal signalling effects. Up to 25 eligible subjects will be enrolled into the trial. Enrollment will stop once 15 subjects have undergone the Jejunal Diversion procedure
- Being tested
- Jejunal Diversion
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jejunal DiversionProcedure or surgery
The jejuno-jejunostomy surgical procedure is a well-known general surgical operation performed for multiple acute and chronic conditions including Crohn's disease, ovarian cancer, and small bowel obstruction. The jejunal diversion procedure is an adaptation of a jejuno-jejunostomy. The proximal end of the anastomosis is approximately 100 cm distal from the ligament of Treitz. The distal end of the anastomosis is approximately 250 cm proximal from the ileocecal junction.
| Study group | Role | What they receive |
|---|---|---|
| Jejunal Diversion | Experimental | all subjects who receive jejunal diversion surgery Receives: Procedure: Jejunal Diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess change in glycosylated hemoglobin A1c
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 posted5 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2016
- Study completionMay 2016
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robin Scamuffa, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283632
- Sponsor's protocol ID
- ESC-14-001
- Status last verified
- Jun 2016
- First submitted
- 31 Oct 2014
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fried M, Dolezalova K, Chambers AP, Fegelman EJ, Scamuffa R, Schwiers ML, Waggoner JR, Haluzik M, Seeley RJ. A novel approach to glycemic control in type 2 diabetes mellitus, partial jejunal diversion: pre-clinical to clinical pathway. BMJ Open Diabetes Res Care. 2017 Sep 1;5(1):e000431. doi: 10.1136/bmjdrc-2017-000431. eCollection 2017.
PubMed 29225893
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of the Jejunal Diversion Procedure (Side-to-side Jejuno-jejunostomy) (Europe)
- ClinicalTrials.gov ID
- NCT02283632
- Acronym / sponsor ID
- ESC-14-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 Nov 2014 (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 site trial to assess metabolic effects in subjects after a Jejunal Diversion procedure was performed.
Detailed description
The Jejunal Diversion procedure is an adaptation of a jejuno-jejunostomy, which is a surgical procedure often used to address a mix of pathological conditions. The safety of the Jejunal Diversion procedure is not in question, but rather understanding the gastrointestinal signalling effects. Up to 25 eligible subjects will be enrolled into the trial. Enrollment will stop once 15 subjects have undergone the Jejunal 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 Diversion | Experimental | Procedure: Jejunal Diversionall subjects who receive jejunal diversion surgery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 20 to 60 years of age (inclusive) on the date the ICD is signed
- A BMI ≥ 27 kg/m2 and < 40 kg/m2
- HbA1c ≥ 8% (63.9 mmol/mol) and ≤ 11% (96.7 mmol/mol)
- C-peptide ≥ 3 ng/mL (0.999 nmol/L)
- At least one of the following:
Key exclusion criteria (23 listed)
- Unable or unwilling to attend follow-up visits and examinations
- History of drug and/or alcohol abuse within 2 years of Screening Visit
- Any previous major GI surgery (e.g., any GI surgery with a resection, etc.) Examples of previous GI surgery allowed include: appendectomy, gall bladder surgery, liver biopsies, endoscopic procedures, etc.
- Scheduled concurrent surgical procedure
- Women of childbearing potential who are pregnant or lactating at the time of screening, at the time of surgery, or planning to become pregnant during the follow-up period
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 DiversionThe jejuno-jejunostomy surgical procedure is a well-known general surgical operation performed for multiple acute and chronic conditions including Crohn's disease, ovarian cancer, and small bowel obstruction. The jejunal diversion procedure is an adaptation of a jejuno-jejunostomy. The proximal end of the anastomosis is approximately 100 cm distal from the ligament of Treitz. The distal end of the anastomosis is approximately 250 cm proximal from the ileocecal junction. | Procedure or surgery | Jejunal Diversion |
Primary outcome
Assess change in glycosylated hemoglobin A1c
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 29 Jun 2016.
- Derived from this study: PubMed 29225893Fried M, Dolezalova K, Chambers AP, Fegelman EJ, Scamuffa R, Schwiers ML, Waggoner JR, Haluzik M, Seeley RJ. A novel approach to glycemic control in type 2 diabetes mellitus, partial jejunal diversion: pre-clinical to clinical pathway. BMJ Open Diabetes Res Care. 2017 Sep 1;5(1):e000431. doi: 10.1136/bmjdrc-2017-000431. eCollection 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.
Robin Scamuffa study director
Ethicon, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jejunal Diversion in people with Diabetes and Obesity, run by Ethicon Endo-Surgery at 1 site in Czechia.
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 11 inclusion and 23 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 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Assess 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 NCT02283632, 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 29 Jun 2016.