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The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones

8 augusti 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

25

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Danmark
      • Hellerup, Danmark, 2900
        • Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Non-diabetic subjects
Obese (BMI > 30 kg/m2) with normal glucose tolerance implanted with the EndoBarrier Gastrointestinal liner
Enhet: EndoBarrier Gastrointestinal Liner
Implantation with the EndoBarrier
Andra namn:
  • DJBS
T2DM subjects
Obese (BMI > 30 kg/m2) with type 2 diabetes implanted with the EndoBarrier Gastrointestinal liner
Enhet: EndoBarrier Gastrointestinal Liner
Implantation with the EndoBarrier
Andra namn:
  • DJBS

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 1 week after implantation
Tidsram: -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
Tidsram: -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 52 weeks after implantation
Tidsram: -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
Tidsram: -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

Sekundära resultatmått

Resultatmått
Tidsram
Change in basal metabolic rate from baseline 1 week after implantation
Tidsram: 0, 50, 210 minutes
0, 50, 210 minutes
Change in basal metabolic rate from baseline 26 weeks after implantation
Tidsram: 0, 50, 210 minutes
0, 50, 210 minutes
Change in basal metabolic rate from baseline 52 weeks after implantation
Tidsram: 0, 50, 210 minutes
0, 50, 210 minutes
Change in basal metabolic rate from baseline 3 weeks after explantation
Tidsram: 0, 50, 210 minutes
0, 50, 210 minutes
Change in gastric emptying from baseline 1 week after implantation
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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 gallbladder emptying from baseline 1 week after implantation
Tidsram: 0, 20, 40, 60, 90, 120, 150, 180
0, 20, 40, 60, 90, 120, 150, 180
Change in gallbladder emptying from baseline 26 weeks after implantation
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 0, 30, 60, 90, 120, 180, 240
0, 30, 60, 90, 120, 180, 240
Change in satiety scores as measured by Visual Analogue Scales 26 weeks after implantation
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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 52 weeks after implantation
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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 3 weeks after explantation
Tidsram: -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 1 week after implantation
Tidsram: -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
Tidsram: -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
Tidsram: -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
Tidsram: -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

Andra resultatmått

Resultatmått
Tidsram
Change in gut microbiota as measured by DNA sequencing from baseline
Tidsram: 52 weeks
52 weeks
Change in body composition from baseline 26 weeks after implantation
Tidsram: 1
1
Change in body composition from baseline 52 weeks after implantation
Tidsram: 1
1
Change in caloric intake as measured by ad libitum meal test 1 week after implantation
Tidsram: 30 minutes
30 minutes
Change in caloric intake as measured by ad libitum meal test 26 weeks after implantation
Tidsram: 30 minutes
30 minutes
Change in caloric intake as measured by ad libitum meal test 52 weeks after implantation
Tidsram: 30 minutes
30 minutes
Change in caloric intake as measured by ad libitum meal test 3 weeks after explantation
Tidsram: 30 minutes
30 minutes

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Filip Krag Knop

Samarbetspartners

University of Copenhagen

Utredare

  • Huvudutredare: Filip K Knop, MD, Ph.D., Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
  • Huvudutredare: Ulrich Rohde, MD, Center for Diabetes Research, Gentofte Hospital, University of Copenhagen

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2013

Primärt slutförande (Faktisk)

1 juni 2017

Avslutad studie (Faktisk)

1 juli 2017

Studieregistreringsdatum

Först inskickad

28 januari 2015

Först inskickad som uppfyllde QC-kriterierna

10 februari 2015

Första postat (Uppskatta)

11 februari 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 augusti 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 augusti 2017

Senast verifierad

1 augusti 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • DJBS meal test

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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