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

Not Applicable

Recruiting

• Conditions: Roux-en-Y gastric bypass; Dumping syndrome; Metabolic and Endocrine - Metabolic disorders; Surgery - Other surgery

• Registration Number: ACTRN12621001599864
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-22
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Male and/or female participants aged 18 – 65 years, who have had Roux-en-Y gastric bypass surgery at least 6 months previously

Exclusion Criteria

•Use of any medication that may influence gastrointestinal motor function that cannot be withheld for the study (e.g. GLP-1 receptor agonists, acarbose, opiates, anticholinergics, levodopa, clonidine, nitrates, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, prucalopride, or erythromycin)
•Uncontrolled diabetes (HbA1c >7.5%)
•Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
•History of chronic gastrointestinal disease (inflammatory bowel disease, coeliac disease) or prior gastrointestinal surgery (other than other than bariatric surgery, uncomplicated appendicectomy or cholecystectomy)
•History of epilepsy
•History of severe respiratory, cardiovascular, hepatic and/or renal disease (severe in that the social or physical manifestation of the disease, or living with the condition, impact negatively and significantly on the individuals’ ability to lead a normal day to day life).
•Impaired renal (as assessed by calculated creatinine clearance < 90 mL/min, iron status, or liver function tests outside the following ranges:
-Alanine aminotransferase (ALT) >3x ULN
-Aspartate transaminase (AST) >3x ULN
-Alkaline phosphatase (ALP) >3x ULN
-Bilirubin >24 mmol/L
-Ferritin <15 ng/mL (Females), <30 ng/mL (Males)
-Haemoglobin <115 g/L (Females), <13 g/L (Males)
•Donation of blood within the previous 3 months
•Participation in any other research studies within the previous 3 months that requires blood sampling
•Exposure to ionising radiation >3mSv for research purposes within the past 12 months
•Vegetarian
•Inability to give informed consent
•Female participants who are pregnant or planning for pregnancy, or are lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified