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Type 2 DiabetesNCT02769728

EndoBarrier in Obese Subjects With Type 2 Diabetes Mellitus

A study testing EndoBarrier in people with Type 2 Diabetes and Obesity, run by Medical University of Graz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes, Obesity
What is being tested?
EndoBarrier
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteAustria
Study dates
Feb 2016to Jan 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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
  • Chronic non-steroidal anti-inflammatory drug (NSAID) or aspirin treatment (Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period)
  • Previous GI surgery that could affect the ability to place the device or the function of the implant
  • GLP-1 receptor agonist therapy
  • Known ischaemic heart disease or heart failure
  • History of stroke
  • Active Helicobacter pylori (Note: Subjects may be enrolled if they had a prior history of Helicobacter Pylori and were successfully treated)
  • Iron deficiency and/or iron deficiency anemia
  • Subjects or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
  • Known malignancy or any other multimorbid patient condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol or would put the participant at an unjustified risk

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Dept. of Internal Medicine, Medical University of Graz

    Graz, 8036

Other trials in Austria

About this study

Official title: EndoBarrierTM in Obese Subjects With Type 2 Diabetes: Impact on Pancreatic Function, Insulin Resistance, Gut Peptides and Gut Permeability - a Pilot Study

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.

Read the detailed description

Obesity and diabetes probably represent the most challenging threat to public health in the 21st century. Obesity has multiple deleterious effects on health, significantly increasing the risk of fatal and non-fatal diseases including type 2 diabetes (T2DM). Bariatric surgery is a well-established method for the treatment of morbid obesity and has increasingly been recognized as an effective, long-lasting treatment option for T2DM.

Recently a potential, non-invasive alternative to bariatric surgery, a duodenal-jejunal bypass liner (EndoBarrierTM) has been introduced. It is an endoscopically implantable and removable device that prevents contact between partially digested nutrients and the proximal intestine. This device was shown to reduce body weight and to improve glycaemic control in subjects with diabetes. Small pilot studies suggested a change in incretin levels, similar to that observed after gastric surgery with an improvement of insulin sensitivity and glucose metabolism. To better understand and characterize the hormonal and/or metabolic effects after the implantation and removal of the EndoBarrierTM, this monocentric, prospective, trial is being performed.

The primary objective of this study is to clarify the changes in gut peptides and gut permeability after implantation the EndoBarrierTM in obese subjects with sub-optimally controlled type 2 diabetes mellitus. Additionally, the investigators aim to determine the changes in body weight and measure of adiposity, the change in global cardiovascular risk from baseline to 12 months as well as the changes in insulin sensitivity and beta-cell function over time.

Being tested
EndoBarrier
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndoBarrierDevice

    Also called duodeno-jejunal bypass liner

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

Study groups in NCT02769728
Study groupRoleWhat they receive
EndoBarrierExperimentalEndoBarrier will be implemented for 9 months.
Receives: Device: EndoBarrier

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline and 9 months

Secondary outcomes (4)

  1. Changes in Glucagon Like Peptide -1 Levels

    Glucagon like peptide -1 levels measured before the Meal Tolerance Test (value at 9 months minus value at baseline)

    Measured: Baseline and 9 months

  2. Changes in Gut Permeability

    Gut permeability measured by the Lactulose/Mannitol Test (value at 9 months minus value at baseline)

    Measured: Baseline and 9 months

  3. Changes in Weight

    Dual-energy X-ray absorptiometry fat mass (value at 9 months minus value at baseline)

    Measured: Baseline and 9 months

  4. Changes in UKPDS Risk Score for Coronary Heart Disease

    The UKPDS Risk Engine provides risk estimates and 95% confidence intervals, in individuals with type 2 diabetes not known to have heart disease, for non-fatal coronary heart disease These can be calculated for any given duration of type 2 diabetes based on current age, sex, ethnicity, smoking status, presence or absence of atrial fibrillation and levels of HbA1c, systolic blood pressure, total cholesterol and HDL cholesterol.

    Units on a scale: 10 year risk to suffer non-fatal coronary heart disease (in %) lower scores mean a better outcome (value at 9 months minus value at baseline)

    Measured: Baseline and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completion1 Dec 2018
  4. Study completionJan 2019

Resources

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
Model description
The endobarrier device was implanted and explanted under general anaesthesia by trained gastroenterologists.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02769728
Sponsor's protocol ID
HS-2014-01
Status last verified
Oct 2023
First submitted
3 May 2016
Last updated
8 Apr 2024
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30539524

Questions about this trial

What is this clinical trial studying?

A study testing EndoBarrier in people with Type 2 Diabetes and Obesity, run by Medical University of Graz at 1 site in Austria.

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 24 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 8 Apr 2024. 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 Austria. 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?

Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Changes in Insulin Sensitivity (time frame: Baseline and 9 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 NCT02769728, 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 8 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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