RecruitingACTRN12621001599864

Relationships of gastric emptying, appetite and gastrointestinal hormones following consumption of solid and liquid food in people who have had gastric bypass surgery for treatment of obesity

Effects of Roux-en-Y gastric bypass on gastric emptying and small intestinal transit of solid and liquid meal components – relationship to effects on appetite and gastrointestinal hormones


Sponsor

The University of Adelaide

Enrollment

15 participants

Start Date

May 23, 2022

Study Type

Interventional

Conditions

Summary

Following Roux-en-Y gastric bypass, a type of surgery to induce weight loss in individuals who are obese, the size of the stomach is considerably reduced and food passes through to the small intestines faster. When food passes through the small intestines, various ‘hormones’ that are thought to assist with weight loss are released and enter the bloodstream. While this seems to be a useful effect, a proportion of patients can experience complications such as having an abnormally low blood sugar level (hypoglycaemia) or low blood pressure after eating. We think this may happen due to these patients producing more of these ‘hormones’ than others. This study will evaluate the movement of solid and liquid food that have been eaten and how it affects the amount of ‘hormones’ produced. Given the smaller size of the stomach, liquids could ‘wash down’ the solid food and increase the amount of ‘hormones’ produced. Learning about how the passage of solid and liquid food through the small intestine changes the amount of ‘hormones’ produced will lead to a better understanding these complications and help us develop new and more effective treatment. This information may also help us improve the dietary advice provided to patients who have had this surgery.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Roux-en-Y gastric bypass is a weight-loss surgery that significantly shrinks the stomach and causes food to move more quickly through the digestive system. While this helps with weight loss, some patients develop complications like low blood sugar (hypoglycaemia) or low blood pressure after eating. Researchers believe these complications may be linked to an exaggerated release of hormones from the small intestine when food — especially liquid mixed with solid — passes through too quickly. This study will ask participants to eat both solid food and liquid separately and together, and then use imaging and blood tests to measure how quickly food moves through their system and how much of these gut hormones are released. By understanding this relationship, researchers hope to improve dietary advice for people who have had gastric bypass and develop new ways to prevent or treat these complications. You may be eligible if you are between 18 and 65 years old, had Roux-en-Y gastric bypass surgery at least 6 months ago, and are not taking certain medications that affect gut movement. Several other medical conditions and dietary restrictions (including being vegetarian) may affect eligibility.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants will be given a solid meal consisting of 50g beef patty (584 kJ) that has been radiolabelled with 20 Mbq of technetium-99m sulphur colloid. The meal will be administered by a trained medi

Participants will be given a solid meal consisting of 50g beef patty (584 kJ) that has been radiolabelled with 20 Mbq of technetium-99m sulphur colloid. The meal will be administered by a trained medical professional and will be consumed over 5 minutes at the research facility. The consumption of the solid meal will be supervised by the medical professional. Following this, gastric emptying data will be acquired in 1-min frames for the first 60 minutes, followed by 3-minute frames until t = 240 minutes. A region-of-interest that corresponds to the gastric pouch will be drawn to derive emptying curves and after 30 minutes, participants will be given a drink consisting of 150ml glucose (50g of glucose, 840kJ) containing 7 MBq gallium-67 EDTA which will include 3g 3-O-methylglucose (3-OMG, Sigma Aldrich USA). The time taken for 50% of the solid food to be emptied from the gastric pouch will be measured. All components are expected to be completed within a single 6 hour session. This intervention will be applied once only per participant.


Locations(2)

The Royal Adelaide Hospital - Adelaide

SA, Australia

The Queen Elizabeth Hospital - Woodville

SA, Australia

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ACTRN12621001599864