The Endocrine Impact of the Duodenal-jejunal Bypass Sleeve on Type 2 Diabetes - Potential Role of the Incretin Hormones
8. august 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
25
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Hellerup, Danmark, 2900
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Obese subjects with or without type 2 diabetes treated with the DJBS will be suitable for participating in the trial
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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
Andre navne:
|
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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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in postprandial glucagon-like peptide-1 (GLP-1) secretion from baseline 1 week after implantation
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in basal metabolic rate from baseline 1 week after implantation
Tidsramme: 0, 50, 210 minutes
|
0, 50, 210 minutes
|
|
Change in basal metabolic rate from baseline 26 weeks after implantation
Tidsramme: 0, 50, 210 minutes
|
0, 50, 210 minutes
|
|
Change in basal metabolic rate from baseline 52 weeks after implantation
Tidsramme: 0, 50, 210 minutes
|
0, 50, 210 minutes
|
|
Change in basal metabolic rate from baseline 3 weeks after explantation
Tidsramme: 0, 50, 210 minutes
|
0, 50, 210 minutes
|
|
Change in gastric emptying from baseline 1 week after implantation
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
Tidsramme: -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
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in gut microbiota as measured by DNA sequencing from baseline
Tidsramme: 52 weeks
|
52 weeks
|
|
Change in body composition from baseline 26 weeks after implantation
Tidsramme: 1
|
1
|
|
Change in body composition from baseline 52 weeks after implantation
Tidsramme: 1
|
1
|
|
Change in caloric intake as measured by ad libitum meal test 1 week after implantation
Tidsramme: 30 minutes
|
30 minutes
|
|
Change in caloric intake as measured by ad libitum meal test 26 weeks after implantation
Tidsramme: 30 minutes
|
30 minutes
|
|
Change in caloric intake as measured by ad libitum meal test 52 weeks after implantation
Tidsramme: 30 minutes
|
30 minutes
|
|
Change in caloric intake as measured by ad libitum meal test 3 weeks after explantation
Tidsramme: 30 minutes
|
30 minutes
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Filip K Knop, MD, Ph.D., Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
- Ledende efterforsker: Ulrich Rohde, MD, Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2013
Primær færdiggørelse (Faktiske)
1. juni 2017
Studieafslutning (Faktiske)
1. juli 2017
Datoer for studieregistrering
Først indsendt
28. januar 2015
Først indsendt, der opfyldte QC-kriterier
10. februar 2015
Først opslået (Skøn)
11. februar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DJBS meal test
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .