Bariatric Procedures and Changes in Incretins and Gastric Emptying

Morbid Obesity Clinical Trial

— BIG  

Official title:

Bariatric Procedures and Changes in Incretins and Gastric Emptying

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539641
• Other study ID #: NL50111.091.14
• Status: Completed
• Phase: N/A
• First received: August 20, 2015
• Last updated: March 27, 2017
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: March 2017
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Radiation:
• Gastric emptying scintigraphy
Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)

Other:
• Determination of gut hormones
Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.

Locations

Country	Name	City	State
Netherlands	Rijnstate hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

de Moura EG, Orso IR, Martins BC, Lopes GS, de Oliveira SL, Galvão-Neto Mdos P, Mancini MC, Santo MA, Sakai P, Ramos AC, Garrido-Júnior 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. — View Citation

Dirksen C, Damgaard M, Bojsen-Møller KN, Jørgensen 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. — View Citation

Escalona A, Yáñez R, Pimentel F, Galvao M, Ramos AC, Turiel D, Boza C, Awruch D, Gersin K, Ibáñez 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. — View Citation

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. — View Citation

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. — View Citation

Wang G, Agenor K, Pizot J, Kotler DP, Harel Y, Van Der Schueren BJ, Quercia I, McGinty J, Laferrère 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying rate after bariatric surgery	In the RYGB and SG group	2 years after surgery
Primary	Change in gastric emptying rate after implantation of DJBL	In the DJBL group	before and 1 month after
Secondary	Gut hormone levels after standard meal		2 years after surgery
Secondary	Weight loss after bariatric surgery		2 years after bariatric surgery
Secondary	Quality of life (SF-36, BAROS) after bariatric surgery		2 years after bariatric surgery
Secondary	Change in quality of life (SF-36, BAROS) after DJBL		Before and 1 month after implantation of DJBL