NCT02360878

Brief Summary

We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose metabolism as well as gut and pancreatic hormone secretion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

4.3 years

First QC Date

January 28, 2015

Last Update Submit

August 8, 2017

Conditions

Type 2 DiabetesObesity

Keywords

DJBSDuodenal-jejunal bypass sleeveDuodenal-jejunal bypass linerEndobarrierObesityType 2 diabetesIncretin hormonesPostprandial glucose metabolism

Outcome Measures

Primary Outcomes (4)

  • Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 1 week after implantation

    -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  • Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 26 weeks after implantation

    -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  • Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 52 weeks after implantation

    -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  • Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 3 weeks after explantation

    -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

Secondary Outcomes (40)

  • Change in basal metabolic rate from baseline 1 week after implantation

    0, 50, 210 minutes

  • Change in basal metabolic rate from baseline 26 weeks after implantation

    0, 50, 210 minutes

  • Change in basal metabolic rate from baseline 52 weeks after implantation

    0, 50, 210 minutes

  • Change in basal metabolic rate from baseline 3 weeks after explantation

    0, 50, 210 minutes

  • Change in gastric emptying from baseline 1 week after implantation

    -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes

  • +35 more secondary outcomes

Other Outcomes (7)

  • Change in gut microbiota as measured by DNA sequencing from baseline

    52 weeks

  • Change in body composition from baseline 26 weeks after implantation

    1

  • Change in body composition from baseline 52 weeks after implantation

    1

  • +4 more other outcomes

Study Arms (2)

Non-diabetic subjects

Obese (BMI \> 30 kg/m2) with normal glucose tolerance implanted with the EndoBarrier Gastrointestinal liner

Device: EndoBarrier Gastrointestinal Liner

T2DM subjects

Obese (BMI \> 30 kg/m2) with type 2 diabetes implanted with the EndoBarrier Gastrointestinal liner

Device: EndoBarrier Gastrointestinal Liner

Interventions

EndoBarrier Gastrointestinal LinerDEVICE

Implantation with the EndoBarrier

Also known as: DJBS
Non-diabetic subjectsT2DM subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese subjects with or without type 2 diabetes treated with the DJBS will be suitable for participating in the trial

You may qualify if:

  • treatment with DJBS
  • written informed consent
  • antidiabetic monotherapy/or diet
  • \> 18 years old
  • not anemic

You may not qualify if:

  • antidiabetic treatment with insulin, GLP-1-agonists, DPP4-inhibitors or more than one orally administered antidiabetic drug.
  • anemia
  • Treatment with DJBS
  • written informed consent
  • not anemic
  • HbA1c \< 6,0% or HbA1c \< 6,5% and normal glucose tolerance test and normal fasting plasma glucose (\< 6,0 mM)
  • HbA1c \> 6,5 % and/or a non-normal glucose tolerance test and/or fasting plasma glucose \> 6,0 mM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Hellerup, 2900, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood feces

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Filip K Knop, MD, Ph.D.

    Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Ulrich Rohde, MD

    Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, Ph.D.

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 11, 2015

Study Start

February 1, 2013

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

August 10, 2017

Record last verified: 2017-08

Locations

DK(1)