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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose metabolism as well as gut and pancreatic hormone secretion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-diabetic subjects | Obese (BMI > 30 kg/m2) with normal glucose tolerance implanted with the EndoBarrier Gastrointestinal liner |
| |
| T2DM subjects | Obese (BMI > 30 kg/m2) with type 2 diabetes implanted with the EndoBarrier Gastrointestinal liner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoBarrier Gastrointestinal Liner | Device | Implantation with the EndoBarrier |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria (obese subjects with type 2 diabetes):
Exclusion Criteria (obese subjects with type 2 diabetes):
Inclusion Criteria (obese subjects without type 2 diabetes):
Exclusion Criteria (obese subjects without type 2 diabetes):
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Obese subjects with or without type 2 diabetes treated with the DJBS will be suitable for participating in the trial
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Diabetes Research, Gentofte Hospital, University of Copenhagen | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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whole blood feces
| 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 |
| Change in gastric emptying from baseline 26 weeks after implantation | -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 | -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 | -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 | 0, 20, 40, 60, 90, 120, 150, 180 |
| Change in gallbladder emptying from baseline 26 weeks after implantation | 0, 20, 40, 60, 90, 120, 150, 180 |
| Change in gallbladder emptying from baseline 52 weeks after implantation | 0, 20, 40, 60, 90, 120, 150, 180 |
| Change in gallbladder emptying from baseline 3 weeks after explantation | 0, 20, 40, 60, 90, 120, 150, 180 |
| Change in satiety scores as measured by Visual Analogue Scales 1 week after implantation | 0, 30, 60, 90, 120, 180, 240 |
| Change in satiety scores as measured by Visual Analogue Scales 26 weeks after implantation | 0, 30, 60, 90, 120, 180, 240 |
| Change in satiety scores as measured by Visual Analogue Scales 52 weeks after implantation | 0, 30, 60, 90, 120, 180, 240 |
| Change in satiety scores as measured by Visual Analogue Scales 3 weeks after explantation | 0, 30, 60, 90, 120, 180, 240 |
| Change in postprandial insulin 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 insulin 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 insulin 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 insulin secretion from baseline 3 weeks after explantation | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes |
| Change in postprandial glucagon secretion 1 week after implantation | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes |
| Change in postprandial glucagon secretion 26 weeks after implantation | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes |
| Change in postprandial glucagon secretion 52 weeks after implantation | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes |
| Change in postprandial glucagon secretion 3 weeks after explantation | -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 | -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 | -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 | -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 | -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 | -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 | -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 | -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 | -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 | -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 | -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 | -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 | -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 | -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 | -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 | -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 | -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes |
| 1 |
| Change in caloric intake as measured by ad libitum meal test 1 week after implantation | 30 minutes |
| Change in caloric intake as measured by ad libitum meal test 26 weeks after implantation | 30 minutes |
| Change in caloric intake as measured by ad libitum meal test 52 weeks after implantation | 30 minutes |
| Change in caloric intake as measured by ad libitum meal test 3 weeks after explantation | 30 minutes |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |