Effects of fat and protein ‘pre-loads’ on Gastric Emptying, Small Intestine transit, gut hormones, glycaemia, plasma insulin, haemodynamics, absorption, appetite and Gastrointestinal symptoms in response to a mixed meal after Roux-en-Y Gastric Bypass

Not Applicable

Completed

• Conditions: Obesity and RYGB surgery; Diet and Nutrition - Obesity; Surgery - Other surgery

• Registration Number: ACTRN12613000718741
• Lead Sponsor: am Nguyen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Subjects who have had have had RYGB (Roux-en-Y Gastric Bypass)
RYGB was performed for at least 6 months ago

Exclusion Criteria

Subjects with a history of severe respiratory, cardiovascular, hepatic and/or renal disease, chronic alcohol abuse or epilepsy (excluded by history)
Subjects requiring medication that may influence gastrointestinal function
No previous history of surgery to the gastrointestinal tract apart from the RYGB or LAGB
Subjects who have been exposed to ionising radiation for research purposes in the past 12 months
Female patients not using appropriate contraceptive method (ie oral contraceptive pill, diaphragm, Depo-Provera hormonal contraceptive injection, intrauterine device (IUD), Norplant method)
Pregnancy and/or breastfeeding mothers
Smoking > 10 cigarettes/day
Alcohol consumption > 20 g/day

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentration of gut hormones (CCK, PYY, ghrelin, GLP-1 and insulin) [Blood samples (approximately 15 ml) will be taken prior (t = -2 mins) to the ingestion of the drink and then at t = 15, 30, 45, 60, 75, 90, 120, 150, 180 and 240 mins];Small intestinal glucose and lipid absorption as measured by a 13C triolein breath test [End-expiratory breath samples will be collected at baseline and every 30 minutes postprandially for 6 hrs. ];Rate of gastric emptying and small intestinal transit as measured by a Gamma camera that will measure the rate at which the stomach empties a 50 or 200ml glucose drink containing 3g of glucose (3-ortho-methyl-D-gluco-pyranose) and a small amount of radiation (which can be detected by the camera)[Gastric emptying curves (expressed as % of the maximum content of the total stomach) will be derived and the content of the total stomach at t = 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210 and 240 mins calculated. The 50% emptying time (T50) will also be obtained.]