- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02539641
Bariatric Procedures and Changes in Incretins and Gastric Emptying (BIG)
The study evaluates the gastric emptying by scintigraphy in patients that had bariatric surgery (RYGB of gastric sleeve) comparing patients with successful and unsuccessful weight loss and in patients before and after the placement of a duodenal-jejunal bypass liner.
Additional, after bariatric surgery gut hormones that influence the gastric emptying rate are determined.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Bariatric surgery reduces stomach volume and passage of foods through the gastrointestinal tract is altered. The satiety level often increases, which is probably caused by gut hormones. Patients response on different bariatric procedures varies widely and it is difficult to predict which patient responds well. Possibly, patients who have successful excess weight loss (EWL) two years after surgery have different gastric emptying rates compared to unsuccessful patients.
Changes in gut hormones after implantation of a duodenal-jejunal bypass liner were demonstrated in other studies. However, gastric emptying before and after placement of this liner is unknown.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Arnhem, Holandsko
- Rijnstate Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Patients must be able to adhere to the study visit schedule and protocol requirements
- Patients must be able to give informed consent and the consent must be obtained prior to any study procedures
- Patients who had a follow-up period up till 2 years after bariatric surgery without any complications or
- Patients are eligible for DJBL implantation
Exclusion Criteria:
- Binge-eating or associated eating disorder
- Active drug or alcohol addiction
- Pregnancy or giving breast feeding
- Gluten allergy
- Inability to stop medication that affects the motility of the upper GI tract (anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids)
- Endocrine disease influencing gastric emptying (diabetes mellitus, hyper- or hypothyroidism). Type 2 diabetes mellitus is not an exclusion criterium for patients receiving the DJBL.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Jiný: Good responder RYGB
Good responders after Roux-en-Y gastric bypass (RYGB).
EWL > 50%.
Interventions: Gastric emptying scintigraphy and Determination of gut hormones.
|
Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)
Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.
|
Jiný: Bad responder RYGB
Bad responders after Roux-en-Y gastric bypass (RYGB).
EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones.
|
Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)
Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.
|
Jiný: Good responder SG
Good responders after sleeve gastrectomy (SG).
EWL > 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones.
|
Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)
Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.
|
Jiný: Bad responder SG
Bad responders after sleeve gastrectomy (SG).
EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones.
|
Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)
Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.
|
Jiný: Duodenal-jejunal bypass liner
Patients who will have a duodenal-jejunal bypass liner (DJBL) Intervention: Gastric emptying scintigraphy before and after implantation of DJBL
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Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Gastric emptying rate after bariatric surgery
Časové okno: 2 years after surgery
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In the RYGB and SG group
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2 years after surgery
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Change in gastric emptying rate after implantation of DJBL
Časové okno: before and 1 month after
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In the DJBL group
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before and 1 month after
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Gut hormone levels after standard meal
Časové okno: 2 years after surgery
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2 years after surgery
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Weight loss after bariatric surgery
Časové okno: 2 years after bariatric surgery
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2 years after bariatric surgery
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Quality of life (SF-36, BAROS) after bariatric surgery
Časové okno: 2 years after bariatric surgery
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2 years after bariatric surgery
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Change in quality of life (SF-36, BAROS) after DJBL
Časové okno: Before and 1 month after implantation of DJBL
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Before and 1 month after implantation of DJBL
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Frits J Berends, MD, PhD, Rijnstate Hospital
Publikace a užitečné odkazy
Obecné publikace
- de Jonge C, Rensen SS, Verdam FJ, Vincent RP, Bloom SR, Buurman WA, le Roux CW, Schaper NC, Bouvy ND, Greve JW. Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes. Obes Surg. 2013 Sep;23(9):1354-60. doi: 10.1007/s11695-013-0921-3.
- de Moura EG, Orso IR, Martins BC, Lopes GS, de Oliveira SL, Galvao-Neto Mdos P, Mancini MC, Santo MA, Sakai P, Ramos AC, Garrido-Junior AB, Halpern A, Cecconello I. Improvement of insulin resistance and reduction of cardiovascular risk among obese patients with type 2 diabetes with the duodenojejunal bypass liner. Obes Surg. 2011 Jul;21(7):941-7. doi: 10.1007/s11695-011-0387-0.
- Braghetto I, Davanzo C, Korn O, Csendes A, Valladares H, Herrera E, Gonzalez P, Papapietro K. Scintigraphic evaluation of gastric emptying in obese patients submitted to sleeve gastrectomy compared to normal subjects. Obes Surg. 2009 Nov;19(11):1515-21. doi: 10.1007/s11695-009-9954-z. Epub 2009 Aug 28.
- Baumann T, Kuesters S, Grueneberger J, Marjanovic G, Zimmermann L, Schaefer AO, Hopt UT, Langer M, Karcz WK. Time-resolved MRI after ingestion of liquids reveals motility changes after laparoscopic sleeve gastrectomy--preliminary results. Obes Surg. 2011 Jan;21(1):95-101. doi: 10.1007/s11695-010-0317-6.
- Gersin KS, Keller JE, Stefanidis D, Simms CS, Abraham DD, Deal SE, Kuwada TS, Heniford BT. Duodenal- jejunal bypass sleeve: a totally endoscopic device for the treatment of morbid obesity. Surg Innov. 2007 Dec;14(4):275-8. doi: 10.1177/1553350607312901.
- Wang G, Agenor K, Pizot J, Kotler DP, Harel Y, Van Der Schueren BJ, Quercia I, McGinty J, Laferrere B. Accelerated gastric emptying but no carbohydrate malabsorption 1 year after gastric bypass surgery (GBP). Obes Surg. 2012 Aug;22(8):1263-7. doi: 10.1007/s11695-012-0656-6. Erratum In: Obes Surg. 2013 Jul;23(7):1016.
- Dirksen C, Damgaard M, Bojsen-Moller KN, Jorgensen NB, Kielgast U, Jacobsen SH, Naver LS, Worm D, Holst JJ, Madsbad S, Hansen DL, Madsen JL. Fast pouch emptying, delayed small intestinal transit, and exaggerated gut hormone responses after Roux-en-Y gastric bypass. Neurogastroenterol Motil. 2013 Apr;25(4):346-e255. doi: 10.1111/nmo.12087. Epub 2013 Jan 29.
- Melissas J, Daskalakis M, Koukouraki S, Askoxylakis I, Metaxari M, Dimitriadis E, Stathaki M, Papadakis JA. Sleeve gastrectomy-a "food limiting" operation. Obes Surg. 2008 Oct;18(10):1251-6. doi: 10.1007/s11695-008-9634-4. Epub 2008 Jul 29.
- Escalona A, Yanez R, Pimentel F, Galvao M, Ramos AC, Turiel D, Boza C, Awruch D, Gersin K, Ibanez L. Initial human experience with restrictive duodenal-jejunal bypass liner for treatment of morbid obesity. Surg Obes Relat Dis. 2010 Mar 4;6(2):126-31. doi: 10.1016/j.soard.2009.12.009. Epub 2010 Jan 20.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NL50111.091.14
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Klinické studie na Gastric emptying scintigraphy
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