Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001711808
Ethics application status
Approved
Date submitted
14/11/2021
Date registered
14/12/2021
Date last updated
30/11/2022
Date data sharing statement initially provided
14/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gastric emptying and hormonal changes in idiopathic reactive hypoglycaemia following a mashed potato meal
Scientific title
Gastric emptying and incretin hormones in idiopathic reactive hypoglycaemia following a mashed potato meal
Secondary ID [1] 305791 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
idiopathic reactive hypoglycaemia 324299 0
Condition category
Condition code
Metabolic and Endocrine 321787 321787 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be given a mashed potato meal consisting of 65g dry potato powder, 20g glucose, 20g margarine labelled with 20 MBq 99mTc-sulfur colloid and 250 ml water (1808 kJ). This meal will be consumed over 5 minutes. Following this, gastric emptying data will be acquired in 1-min frames for the first 60 minutes, followed by 3-minute frames for 240 minutes following complete consumption of the meal. The meal will be administered by a trained medical officer and will be consumed over 5 minutes, supervised by the medical officer, at the research facility. A gastric ‘region-of-interest’ will be drawn to derive emptying curves and the amount of the meal remaining in the stomach will be calculated. Caecal arrival time will be calculated as the time taken for the labelled drink to travel from the mouth to the caecum using a cobalt marker placed over the right iliac fossa. The time taken for 50% of the meal to be emptied from the stomach will be measured using scintigraphy. All components are expected to be completed within a single 6 hour session. This intervention will be applied once only per participant.
Intervention code [1] 322187 0
Diagnosis / Prognosis
Comparator / control treatment
Twenty age and sex-matched healthy controls will be included
Control group
Active

Outcomes
Primary outcome [1] 329551 0
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.
Timepoint [1] 329551 0
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.
Secondary outcome [1] 402943 0
Plasma glucose concentration
Timepoint [1] 402943 0
Immediately before the test meal and at t= 10, 15, 20, 30, 45, 60, 90 ,120, 180, 240. (t=0 is time of completion of the meal)
Secondary outcome [2] 402963 0
Plasma concentrations of GLP-1 (glucagon-like peptide-1)
Timepoint [2] 402963 0
Immediately before the test meal and at t= 10, 15, 20, 30, 45, 60, 90 ,120, 180, 240. (t=0 is time of completion of the meal)
Secondary outcome [3] 402964 0
Plasma concentrations of GIP (glucose dependent insulinotropic polypeptide)
Timepoint [3] 402964 0
Immediately before the test meal and at t= 10, 15, 20, 30, 45, 60, 90 ,120, 180, 240. (t=0 is time of completion of the meal)
Secondary outcome [4] 402965 0
Plasma concentrations of insulin
Timepoint [4] 402965 0
Immediately before the test meal and at t= 10, 15, 20, 30, 45, 60, 90 ,120, 180, 240. (t=0 is time of completion of the meal)
Secondary outcome [5] 402966 0
Plasma concentrations of C-peptide
Timepoint [5] 402966 0
Immediately before the test meal and at t= 10, 15, 20, 30, 45, 60, 90 ,120, 180, 240. (t=0 is time of completion of the meal)
Secondary outcome [6] 402967 0
Plasma concentrations of glucagon
Timepoint [6] 402967 0
Immediately before the test meal and at t= 10, 15, 20, 30, 45, 60, 90 ,120, 180, 240. (t=0 is time of completion of the meal)
Secondary outcome [7] 402968 0
Caecal arrival time
Timepoint [7] 402968 0
Time taken from consumption of the meal to the detection of the radio-labelled meal in the caecal region by the gamma camera, guided by a cobalt marker placed in the right iliac fossa.
Secondary outcome [8] 402969 0
Plasma cortisol concentration
Timepoint [8] 402969 0
Immediately before the test meal and at t= 10, 15, 20, 30, 45, 60, 90 ,120, 180, 240. (t=0 is time of completion of the meal)
Secondary outcome [9] 402970 0
Plasma normetanephrine concentration
Timepoint [9] 402970 0
Immediately before the test meal and at t= 10, 15, 20, 30, 45, 60, 90 ,120, 180, 240. (t=0 is time of completion of the meal)
Secondary outcome [10] 402971 0
Plasma adrenaline concentration
Timepoint [10] 402971 0
Immediately before the test meal and at t= 10, 15, 20, 30, 45, 60, 90 ,120, 180, 240. (t=0 is time of completion of the meal)
Secondary outcome [11] 402972 0
Symptoms of hypoglycaemia evaluated using a scaled questionnaire. Reference: Jones TW, Porter P, Sherwin RS, Davis EA, O'Leary P, Frazer F, Byrne G, Stick S, Tamborlane W 1998 Decreased epinephrine responses to hypoglycemia during sleep. N Engl J Med 338:1657-1662.
Timepoint [11] 402972 0
Immediately before the test meal and at t= 15, 30, 60, 90, 120, 150, 180, 210, 240. (t=0 is time of completion of the meal)
Secondary outcome [12] 402973 0
Fullness by visual analogue scale
Timepoint [12] 402973 0
Immediately before the test meal and at t= 15, 30, 60, 90, 120, 150, 180, 210, 240. (t=0 is time of completion of the meal)
Secondary outcome [13] 402974 0
Blood pressure measured using sphygmomanometer
Timepoint [13] 402974 0
Measured immediately before test meal and then at 5-minute intervals until t = 240 min post test meal completion.
Secondary outcome [14] 402975 0
Heart rate measured using a pulse oximeter
Timepoint [14] 402975 0
Measured immediately before test meal and then at 5-minute intervals until t = 240 min post test meal completion.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All participants will receive the same intervention, however the response of individuals with idiopathic reactive hypoglycaemia will be compared to age- and sex-matched healthy controls
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/01/2022
Actual
13/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 310146 0
Government body
Name [1] 310146 0
National Health and Medical Research Council
Country [1] 310146 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Adelaide Health and Medical Science Building
4 North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 311220 0
None
Name [1] 311220 0
None
Address [1] 311220 0
Not applicable
Country [1] 311220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309834 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 309834 0
Ethics committee country [1] 309834 0
Australia
Date submitted for ethics approval [1] 309834 0
Approval date [1] 309834 0
09/11/2021
Ethics approval number [1] 309834 0
2021/HRE00298

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115546 0
Prof Michael Horowitz
Address 115546 0
The University of Adelaide
Level 5 Adelaide Health and Medical Science Building
4 North Terrace
Adelaide SA 5000
Country 115546 0
Australia
Phone 115546 0
+61 870742673
Fax 115546 0
Email 115546 0
[email protected]
Contact person for public queries
Name 115547 0
Ryan Jalleh
Address 115547 0
The University of Adelaide
Level 5 Adelaide Health and Medical Science Building
4 North Terrace
Adelaide SA 5000
Country 115547 0
Australia
Phone 115547 0
+61 883131393
Fax 115547 0
Email 115547 0
[email protected]
Contact person for scientific queries
Name 115548 0
Ryan Jalleh
Address 115548 0
The University of Adelaide
Level 5 Adelaide Health and Medical Science Building
4 North Terrace
Adelaide SA 5000
Country 115548 0
Australia
Phone 115548 0
+61 883131393
Fax 115548 0
Email 115548 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.