EndoBarrier in Obese Subjects With Type 2 Diabetes Mellitus

NCT02769728 | Completed Results

• 1 other identifier: HS-2014-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to explore short and longer-term effects of the Endobarrier™ implantation on insulin resistance and beta-cell function assessed by repeated Botnia clamps. In addition changes in gut peptides and gut permeability after implantation of a removable duodeno-jejunal bypass device to induce diabetes remission in obese subjects with sub-optimally controlled type 2 diabetes mellitus will be determined. Further changes in body weight and body composition, the change in global cardiovascular risk from baseline to 12 months, estimated using the UKPDS risk engine will be recorded.

Conditions

Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in Insulin Sensitivity

  insulin sensitivity: measured by mean glucose infusion rate (in a hyperinsulinaemic-euglycaemic clamp) (value at 9 months minus value at baseline)

  Baseline and 9 months

Secondary Outcomes (4)

• Changes in Glucagon Like Peptide -1 Levels

  Baseline and 9 months

• Changes in Gut Permeability

  Baseline and 9 months

• Changes in Weight

  Baseline and 9 months

• Changes in UKPDS Risk Score for Coronary Heart Disease

  Baseline and 9 months

Study Arms (1)

EndoBarrier

EXPERIMENTAL

EndoBarrier will be implemented for 9 months.

Device: EndoBarrier

Interventions

EndoBarrier DEVICE

implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus

Also known as: duodeno-jejunal bypass liner

EndoBarrier

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Type 2 diabetes
• BMI 30-49 kg/m²
• HbA1c ≥ 6.5% (48 mmol/mol)
• Appropriate life style intervention measures have been tried but have failed to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months
• Person is generally fit for intervention
• Person commits to the need for long-term follow-up

You may not qualify if:

• Type 1 diabetes mellitus
• Maturity Onset Diabetes of the Young (MODY)
• Secondary diabetes due to a specific disease or glucocorticoid therapy
• Pregnancy or women of childbearing age without adequate contraception
• Women who are breast-feeding
• Hypothalamic cause of obesity, Cushing syndrome
• Major psychiatric disease including diagnosed eating disorders, history of drug or alcohol abuse
• History of bariatric surgery or complex abdominal surgery
• Inflammatory bowel disease
• Pancreatitis
• Cholelithiasis
• Uncontrolled gastroesophageal reflux
• Known upper GI bleeding conditions, e.g. gastric or esophageal varices
• Congenital or acquired abnormalities of the upper GI tract, e.g. stenosis
• Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Dept. of Internal Medicine, Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (1)

• Tripolt NJ, Aberer F, Url J, Hogenauer C, Schreiber F, Eherer A, Sourij C, Obermayer AM, Stadlbauer V, Svehlikova E, Brunner M, Kojzar H, Pferschy PN, Pieber TR, Sourij H. Impact of Duodeno-Jejunal Bypass Liner (EndoBarrierTM) Implantation on Insulin Sensitivity in Patients with Type 2 Diabetes Mellitus (T2DM): A Study Protocol for a Pilot Trial. Diabetes Ther. 2019 Feb;10(1):299-309. doi: 10.1007/s13300-018-0540-z. Epub 2018 Dec 11.

  PMID: 30539524 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; 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

Results Point of Contact

• Title: Prof. Harald Sourij
• Organization: Medical University of Graz

ha.sourij@medunigraz.at

0316 385 81310

Study Officials

• Harald Sourij, MD

  Medical University of Graz, Auenbruggerplatz 15

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The endobarrier device was implanted and explanted under general anaesthesia by trained gastroenterologists.

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 12, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: April 8, 2024
• Results First Posted: April 8, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)