Bariatric Procedures and Changes in Incretins and Gastric Emptying

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Bariatric Procedures and Changes in Incretins and Gastric Emptying

Conditions
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Morbid Obesity

Intervention / Treatment
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* Radiation: Gastric emptying scintigraphy
* Other: Determination of gut hormones


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Good responder RYGB<br>Good responders after Roux-en-Y gastric bypass (RYGB). EWL > 50%. Interventions: Gastric emptying scintigraphy and Determination of gut hormones. | Radiation: Gastric emptying scintigraphy<br>* Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)<br>Other: Determination of gut hormones<br>* Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.<br>|
| Other: Bad responder RYGB<br>Bad responders after Roux-en-Y gastric bypass (RYGB). EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones. | Radiation: Gastric emptying scintigraphy<br>* Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)<br>Other: Determination of gut hormones<br>* Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.<br>|
| Other: Good responder SG<br>Good responders after sleeve gastrectomy (SG). EWL > 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones. | Radiation: Gastric emptying scintigraphy<br>* Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)<br>Other: Determination of gut hormones<br>* Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.<br>|
| Other: Bad responder SG<br>Bad responders after sleeve gastrectomy (SG). EWL < 50% Interventions: Gastric emptying scintigraphy and Determination of gut hormones. | Radiation: Gastric emptying scintigraphy<br>* Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)<br>Other: Determination of gut hormones<br>* Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.<br>|
| Other: Duodenal-jejunal bypass liner<br>Patients who will have a duodenal-jejunal bypass liner (DJBL) Intervention: Gastric emptying scintigraphy before and after implantation of DJBL | Radiation: Gastric emptying scintigraphy<br>* Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying rate after bariatric surgery | In the RYGB and SG group | 2 years after surgery | 
| Change in gastric emptying rate after implantation of DJBL | In the DJBL group | before and 1 month after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut hormone levels after standard meal |  | 2 years after surgery | 
| Weight loss after bariatric surgery |  | 2 years after bariatric surgery | 
| Quality of life (SF-36, BAROS) after bariatric surgery |  | 2 years after bariatric surgery | 
| Change in quality of life (SF-36, BAROS) after DJBL |  | Before and 1 month after implantation of DJBL |