The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones
8. August 2017 aktualisiert von: Filip Krag Knop
We want to evaluate the impact of the EndoBarrier Gastrointestinal Liner (DJBS) on glucose metabolism as well as gut and pancreatic hormone secretion.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
25
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Hellerup, Dänemark, 2900
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Obese subjects with or without type 2 diabetes treated with the DJBS will be suitable for participating in the trial
Beschreibung
Inclusion Criteria (obese subjects with type 2 diabetes):
- treatment with DJBS
- written informed consent
- antidiabetic monotherapy/or diet
- > 18 years old
- not anemic
Exclusion Criteria (obese subjects with type 2 diabetes):
- 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
- 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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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Non-diabetic subjects
Obese (BMI > 30 kg/m2) with normal glucose tolerance implanted with the EndoBarrier Gastrointestinal liner
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Implantation with the EndoBarrier
Andere Namen:
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T2DM subjects
Obese (BMI > 30 kg/m2) with type 2 diabetes implanted with the EndoBarrier Gastrointestinal liner
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Implantation with the EndoBarrier
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 1 week after implantation
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
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Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 52 weeks after implantation
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change in basal metabolic rate from baseline 1 week after implantation
Zeitfenster: 0, 50, 210 minutes
|
0, 50, 210 minutes
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Change in basal metabolic rate from baseline 26 weeks after implantation
Zeitfenster: 0, 50, 210 minutes
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0, 50, 210 minutes
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Change in basal metabolic rate from baseline 52 weeks after implantation
Zeitfenster: 0, 50, 210 minutes
|
0, 50, 210 minutes
|
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Change in basal metabolic rate from baseline 3 weeks after explantation
Zeitfenster: 0, 50, 210 minutes
|
0, 50, 210 minutes
|
|
Change in gastric emptying from baseline 1 week after implantation
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
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Change in gallbladder emptying from baseline 1 week after implantation
Zeitfenster: 0, 20, 40, 60, 90, 120, 150, 180
|
0, 20, 40, 60, 90, 120, 150, 180
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Change in gallbladder emptying from baseline 26 weeks after implantation
Zeitfenster: 0, 20, 40, 60, 90, 120, 150, 180
|
0, 20, 40, 60, 90, 120, 150, 180
|
|
Change in gallbladder emptying from baseline 52 weeks after implantation
Zeitfenster: 0, 20, 40, 60, 90, 120, 150, 180
|
0, 20, 40, 60, 90, 120, 150, 180
|
|
Change in gallbladder emptying from baseline 3 weeks after explantation
Zeitfenster: 0, 20, 40, 60, 90, 120, 150, 180
|
0, 20, 40, 60, 90, 120, 150, 180
|
|
Change in satiety scores as measured by Visual Analogue Scales 1 week after implantation
Zeitfenster: 0, 30, 60, 90, 120, 180, 240
|
0, 30, 60, 90, 120, 180, 240
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Change in satiety scores as measured by Visual Analogue Scales 26 weeks after implantation
Zeitfenster: 0, 30, 60, 90, 120, 180, 240
|
0, 30, 60, 90, 120, 180, 240
|
|
Change in satiety scores as measured by Visual Analogue Scales 52 weeks after implantation
Zeitfenster: 0, 30, 60, 90, 120, 180, 240
|
0, 30, 60, 90, 120, 180, 240
|
|
Change in satiety scores as measured by Visual Analogue Scales 3 weeks after explantation
Zeitfenster: 0, 30, 60, 90, 120, 180, 240
|
0, 30, 60, 90, 120, 180, 240
|
|
Change in postprandial insulin secretion from baseline 1 week after implantation
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
|
Change in postprandial glucagon secretion 1 week after implantation
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
|
Change in postprandial glucagon secretion 26 weeks after implantation
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
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Change in postprandial glucagon secretion 52 weeks after implantation
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
|
Change in postprandial glucagon secretion 3 weeks after explantation
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
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Change in postprandial ghrelin from baseline 3 weeks after explantation
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
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Change in postprandial glucosedependent insulinotropic peptide (GIP) from baseline 1 week after implantation
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-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
Zeitfenster: -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
-30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240 minutes
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change in gut microbiota as measured by DNA sequencing from baseline
Zeitfenster: 52 weeks
|
52 weeks
|
|
Change in body composition from baseline 26 weeks after implantation
Zeitfenster: 1
|
1
|
|
Change in body composition from baseline 52 weeks after implantation
Zeitfenster: 1
|
1
|
|
Change in caloric intake as measured by ad libitum meal test 1 week after implantation
Zeitfenster: 30 minutes
|
30 minutes
|
|
Change in caloric intake as measured by ad libitum meal test 26 weeks after implantation
Zeitfenster: 30 minutes
|
30 minutes
|
|
Change in caloric intake as measured by ad libitum meal test 52 weeks after implantation
Zeitfenster: 30 minutes
|
30 minutes
|
|
Change in caloric intake as measured by ad libitum meal test 3 weeks after explantation
Zeitfenster: 30 minutes
|
30 minutes
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Filip K Knop, MD, Ph.D., Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
- Hauptermittler: Ulrich Rohde, MD, Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 2013
Primärer Abschluss (Tatsächlich)
1. Juni 2017
Studienabschluss (Tatsächlich)
1. Juli 2017
Studienanmeldedaten
Zuerst eingereicht
28. Januar 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. Februar 2015
Zuerst gepostet (Schätzen)
11. Februar 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. August 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. August 2017
Zuletzt verifiziert
1. August 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- DJBS meal test
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