A Trial of the Jejunal Diversion Procedure

NCT02283632 | Completed

• 1 other identifier: ESC-14-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Assess change in glycosylated hemoglobin A1c

  12 months

Study Arms (1)

Jejunal Diversion

EXPERIMENTAL

all subjects who receive jejunal diversion surgery

Procedure: Jejunal Diversion

Interventions

Jejunal Diversion PROCEDURE

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.

Jejunal Diversion

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (1)

OB KlINIKA

Prague, Czechia

Location

Related Publications (1)

• 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.

  PMID: 29225893 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robin Scamuffa

  Ethicon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 5, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

CZ (1)