Gastric emptying and hormonal changes in idiopathic reactive hypoglycaemia following a mashed potato meal

Not Applicable

Recruiting

• Conditions: idiopathic reactive hypoglycaemia; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12621001711808
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-14
• Last Update Posted: 5 December 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Male and female aged 18 – 70 years, who have been diagnosed with idiopathic reactive hypoglycaemia by a primary care physician or endocrinologist

For the control group:
Male and female aged 18 - 70 years who do not have any hypoglycaemic disorder

Exclusion Criteria

•History of type 1 or type 2 diabetes
•Use of any medication that may influence gastrointestinal motor function, glycaemia, body weight or appetite (e.g. glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase 4 inhibitors, opiates, 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 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) >2x ULN
-Aspartate transaminase (AST) >2x ULN
-Alkaline phosphatase (ALP) >2x 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time taken for 50% of the meal (containing 65g dry potato powder, 20g glucose, 20g margarine labelled with 20 MBq 99mTc-sulfur colloid and 250 ml water) to empty from the gastric pouch assessed using gamma camera images.[Gastric emptying image data will be acquired every minute for the first 60 minutes post meal then every 3 minutes until 240 minutes post-meal.]