Type 2 DiabetesNCT02360878
The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones
An observational study of Type 2 Diabetes and Obesity, run by Filip Krag Knop at 1 site in Denmark.
Trial summary
We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose metabolism as well as gut and pancreatic hormone secretion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- EndoBarrier Gastrointestinal Liner
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obese subjects with or without type 2 diabetes treated with the DJBS will be suitable for participating in the trial
Who may be able to join
- treatment with DJBS
- written informed consent
- antidiabetic monotherapy/or diet
- > 18 years old
- not anemic
Who cannot join
- antidiabetic treatment with insulin, GLP-1-agonists, DPP4-inhibitors or more than one orally administered antidiabetic drug.
- anemia
- Inclusion Criteria (obese subjects without type 2 diabetes):
- Treatment with DJBS
- written informed consent
- not anemic
Show all 9Show fewer
- HbA1c < 6,0% or HbA1c < 6,5% and normal glucose tolerance test and normal fasting plasma glucose (< 6,0 mM)
- Exclusion Criteria (obese subjects without type 2 diabetes):
- HbA1c > 6,5 % and/or a non-normal glucose tolerance test and/or fasting plasma glucose > 6,0 mM
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
Hellerup, 2900
About this study
We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose metabolism as well as gut and pancreatic hormone secretion.
Read the detailed description
Duodenal-jejunal bypass sleeve (DJBS) is being developed for the treatment of obesity, and initial clinical outcomes suggest that this minimally invasive endoscopic technique potentially has beneficial effects on type 2 diabetes also. However, the mechanisms behind the antidiabetic effects of the procedure remain unknown. We want to elucidate how the DJBS might change postprandial secretion of gut and pancreatic hormones.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- EndoBarrier Gastrointestinal Liner
- Keywords
- DJBS, Duodenal-jejunal bypass sleeve, Duodenal-jejunal bypass liner, Endobarrier, Obesity, Type 2 diabetes, Incretin hormones, Postprandial glucose metabolism
- 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.
EndoBarrier Gastrointestinal LinerDevice
Also called DJBS
Implantation with the EndoBarrier
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetic subjects | Obese (BMI > 30 kg/m2) with normal glucose tolerance implanted with the EndoBarrier Gastrointestinal liner Receives: Device: EndoBarrier Gastrointestinal Liner | |
| T2DM subjects | Obese (BMI > 30 kg/m2) with type 2 diabetes implanted with the EndoBarrier Gastrointestinal liner Receives: Device: EndoBarrier Gastrointestinal Liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 1 week after implantation
Measured: -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
Measured: -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
Measured: -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
Measured: -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
Measured: 0, 50, 210 minutes
Change in basal metabolic rate from baseline 26 weeks after implantation
Measured: 0, 50, 210 minutes
Change in basal metabolic rate from baseline 52 weeks after implantation
Measured: 0, 50, 210 minutes
Change in basal metabolic rate from baseline 3 weeks after explantation
Measured: 0, 50, 210 minutes
Change in gastric emptying from baseline 1 week after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in gastric emptying from baseline 26 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in gastric emptying from baseline 52 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in gastric emptying from baseline 3 weeks after explantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in gallbladder emptying from baseline 1 week after implantation
Measured: 0, 20, 40, 60, 90, 120, 150, 180
Change in gallbladder emptying from baseline 26 weeks after implantation
Measured: 0, 20, 40, 60, 90, 120, 150, 180
Change in gallbladder emptying from baseline 52 weeks after implantation
Measured: 0, 20, 40, 60, 90, 120, 150, 180
Change in gallbladder emptying from baseline 3 weeks after explantation
Measured: 0, 20, 40, 60, 90, 120, 150, 180
Change in satiety scores as measured by Visual Analogue Scales 1 week after implantation
Measured: 0, 30, 60, 90, 120, 180, 240
Change in satiety scores as measured by Visual Analogue Scales 26 weeks after implantation
Measured: 0, 30, 60, 90, 120, 180, 240
Change in satiety scores as measured by Visual Analogue Scales 52 weeks after implantation
Measured: 0, 30, 60, 90, 120, 180, 240
Change in satiety scores as measured by Visual Analogue Scales 3 weeks after explantation
Measured: 0, 30, 60, 90, 120, 180, 240
Change in postprandial insulin secretion from baseline 1 week after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial insulin secretion from baseline 26 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial insulin secretion from baseline 52 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial insulin secretion from baseline 3 weeks after explantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucagon secretion 1 week after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucagon secretion 26 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucagon secretion 52 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucagon secretion 3 weeks after explantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucose from baseline 1 week after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucose from baseline 26 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucose from baseline 52 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucose form baseline 3 weeks after explantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial PYY from baseline 1 week after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial PYY from baseline 26 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial PYY from baseline 52 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial PYY from baseline 3 weeks after explantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial ghrelin from baseline 1 week after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial ghrelin from baseline 26 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial ghrelin from baseline 52 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial ghrelin from baseline 3 weeks after explantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 1 week after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 26 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 52 weeks after implantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 3 weeks after explantation
Measured: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startFeb 2013
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Filip Krag Knop
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor-investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip K Knop, MD, Ph.D., Principal investigator, Center for Diabetes Research, Gentofte Hospital, University of CopenhagenUlrich Rohde, MD, Principal investigator, Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360878
- Sponsor's protocol ID
- DJBS meal test
- Status last verified
- Aug 2017
- First submitted
- 28 Jan 2015
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones
- ClinicalTrials.gov ID
- NCT02360878
- Acronym / sponsor ID
- DJBS meal test
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- DJBS, Duodenal-jejunal bypass sleeve, Duodenal-jejunal bypass liner, Endobarrier, Obesity, Type 2 diabetes, Incretin hormones, Postprandial glucose metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Filip Krag KnopUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Feb 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose metabolism as well as gut and pancreatic hormone secretion.
Detailed description
Duodenal-jejunal bypass sleeve (DJBS) is being developed for the treatment of obesity, and initial clinical outcomes suggest that this minimally invasive endoscopic technique potentially has beneficial effects on type 2 diabetes also. However, the mechanisms behind the antidiabetic effects of the procedure remain unknown. We want to elucidate how the DJBS might change postprandial secretion of gut and pancreatic hormones.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic subjects | – | Device: EndoBarrier Gastrointestinal LinerObese (BMI > 30 kg/m2) with normal glucose tolerance implanted with the EndoBarrier Gastrointestinal liner |
| T2DM subjects | – | Device: EndoBarrier Gastrointestinal LinerObese (BMI > 30 kg/m2) with type 2 diabetes implanted with the EndoBarrier Gastrointestinal liner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obese subjects with or without type 2 diabetes treated with the DJBS will be suitable for participating in the trial
Key inclusion criteria (5 listed)
- treatment with DJBS
- written informed consent
- antidiabetic monotherapy/or diet
- > 18 years old
- not anemic
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoBarrier Gastrointestinal LinerAlso: DJBSImplantation with the EndoBarrier | Device | Non-diabetic subjects, T2DM subjects |
Primary outcome
Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 1 week after implantation
Time frame: -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
Time frame: -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
Time frame: -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
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
40 secondary outcomes
Change in basal metabolic rate from baseline 1 week after implantation
Time frame: 0, 50, 210 minutes
Change in basal metabolic rate from baseline 26 weeks after implantation
Time frame: 0, 50, 210 minutes
Change in basal metabolic rate from baseline 52 weeks after implantation
Time frame: 0, 50, 210 minutes
Change in basal metabolic rate from baseline 3 weeks after explantation
Time frame: 0, 50, 210 minutes
Change in gastric emptying from baseline 1 week after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in gastric emptying from baseline 26 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in gastric emptying from baseline 52 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in gastric emptying from baseline 3 weeks after explantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in gallbladder emptying from baseline 1 week after implantation
Time frame: 0, 20, 40, 60, 90, 120, 150, 180
Change in gallbladder emptying from baseline 26 weeks after implantation
Time frame: 0, 20, 40, 60, 90, 120, 150, 180
Change in gallbladder emptying from baseline 52 weeks after implantation
Time frame: 0, 20, 40, 60, 90, 120, 150, 180
Change in gallbladder emptying from baseline 3 weeks after explantation
Time frame: 0, 20, 40, 60, 90, 120, 150, 180
Change in satiety scores as measured by Visual Analogue Scales 1 week after implantation
Time frame: 0, 30, 60, 90, 120, 180, 240
Change in satiety scores as measured by Visual Analogue Scales 26 weeks after implantation
Time frame: 0, 30, 60, 90, 120, 180, 240
Change in satiety scores as measured by Visual Analogue Scales 52 weeks after implantation
Time frame: 0, 30, 60, 90, 120, 180, 240
Change in satiety scores as measured by Visual Analogue Scales 3 weeks after explantation
Time frame: 0, 30, 60, 90, 120, 180, 240
Change in postprandial insulin secretion from baseline 1 week after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial insulin secretion from baseline 26 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial insulin secretion from baseline 52 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial insulin secretion from baseline 3 weeks after explantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucagon secretion 1 week after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucagon secretion 26 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucagon secretion 52 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucagon secretion 3 weeks after explantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucose from baseline 1 week after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucose from baseline 26 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucose from baseline 52 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucose form baseline 3 weeks after explantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial PYY from baseline 1 week after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial PYY from baseline 26 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial PYY from baseline 52 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial PYY from baseline 3 weeks after explantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial ghrelin from baseline 1 week after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial ghrelin from baseline 26 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial ghrelin from baseline 52 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial ghrelin from baseline 3 weeks after explantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 1 week after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 26 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 52 weeks after implantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 3 weeks after explantation
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip K Knop, MD, Ph.D. principal investigator
Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
Ulrich Rohde, MD principal investigator
Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Obesity, run by Filip Krag Knop at 1 site in Denmark.
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 5 inclusion and 9 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 10 Aug 2017. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 1 week after implantation (time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2017.