A prospective study on post-meal low blood sugar levels following weight loss surgery.

Not Applicable

• Conditions: Post bariatric hypoglycaemia; Roux-en-Y gastric bypass; One anastomosis gastric bypass; Post-prandial hypotension; Metabolic and Endocrine - Other endocrine disorders; Surgery - Other surgery

• Registration Number: ACTRN12622000615785
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-26
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Males and females with or without diabetes who are planned to have Roux-en-Y gastric bypass or one anastomosis gastric bypass.

Exclusion Criteria

•Use of any medication that may influence gastrointestinal motor function, body weight or appetite (glucagon-like peptide 1 receptor agonists, dipeptidyl peptidase 4 inhibitors, opiates, anticholinergics, levodopa, clonidine, nitrates, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, prucalopride, or erythromycin)
•Evidence of drug abuse, consumption of more than 20 g alcohol per day or an active smoking history
•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
•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), <130 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 or exposure to radiation
•Inability to give informed consent
•Female participants who are pregnant or planning for pregnancy, or are lactating
•Vegetarian

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak plasma concentration of glucagon-like peptide-1 (GLP-1) measured pre-surgery and at the 6 month post-surgery follow up.[Plasma GLP-1 will be measured immediately before the test meal and at t = 15, 30, 60, 90, 120, 180, 240 min post test meal completion at the pre-surgery and the 6 month post-surgery follow up study.]