A Trial of the Jejunal Diversion Procedure

Obesity Clinical Trial

Official title:

A Trial of the Jejunal Diversion Procedure (Side-to-side Jejuno-jejunostomy) (Europe)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283632
• Other study ID #: ESC-14-001
• Status: Completed
• Phase: N/A
• First received: October 31, 2014
• Last updated: June 28, 2016
• Start date: October 2014
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This is a single site trial to assess metabolic effects in subjects after a Jejunal Diversion procedure was performed.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 20 to 60 years of age (inclusive) on the date the ICD is signed

2. A BMI = 27 kg/m2 and < 40 kg/m2

3. HbA1c = 8% (63.9 mmol/mol) and = 11% (96.7 mmol/mol)

4. C-peptide = 3 ng/mL (0.999 nmol/L)

5. At least one of the following:

1. Systolic BP = 140 mmHg and/or diastolic BP = 90 mmHg, or on anti-hypertensive medication

2. HDL < 40 mg/dL (1.0344 mmol/L) (men) or < 50 mg/dL (1.293 mmol/L) (women), or on medication for low HDL

3. LDL > 100 mg/dL (2.586 mmol/L), or on medication for high LDL

4. TG = 150 mg/dL (1.694 mmol/L) or on TG lowering medication treatment

5. FPG = 100 mg/dL (5.556 mmol/L) or on medication for hyperglycemia or anti-T2DM

6. Able to comprehend and sign the EC-approved trial ICD

Exclusion Criteria:

1. Unable or unwilling to attend follow-up visits and examinations

2. History of drug and/or alcohol abuse within 2 years of Screening Visit

3. 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.

4. Scheduled concurrent surgical procedure

5. 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

6. Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression, or history of suicide attempts

7. Any condition which precludes compliance with the trial, including:

1. 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

2. History of Hepatitis B or C

3. T1DM

4. LADA (confirmed by positive GAD autoantibodies, IAA, and ICA)

5. Immunocompromised such as that resulting from chronic oral steroid use, cancer chemotherapeutic agents, or immune deficiency disorders

8. Screening laboratory tests with any of the following:

1. ALT and/or AST levels = 4 times ULN according to laboratory normal ranges

2. Blood creatinine level = 1.5 times ULN according to laboratory normal ranges

3. BUN level = 1.5 times ULN according to laboratory normal ranges

9. Use of any of the following medications in the past 120 days:

1. Chronic steroid use

2. Prescription or over-the-counter medications or supplements with a primary indication known to cause or assist in weight reduction

10. Use of any of the following medications in the past 60 days:

a. Promotility agents

11. Any other medical condition or finding for which, at the discretion of the PI, the subject should be excluded

12. 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Procedure:
• Jejunal Diversion
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.

Locations

Country	Name	City	State
Czech Republic	OB KlINIKA	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess change in glycosylated hemoglobin A1c		12 months	No