Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001599864
Ethics application status
Approved
Date submitted
14/10/2021
Date registered
22/11/2021
Date last updated
24/10/2022
Date data sharing statement initially provided
22/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
Effects of Roux-en-Y gastric bypass on gastric emptying and small intestinal transit of solid and liquid meal components – relationship to effects on appetite and gastrointestinal hormones
Secondary ID [1] 305441 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Roux-en-Y gastric bypass 323816 0
Dumping syndrome 324174 0
Condition category
Condition code
Metabolic and Endocrine 321315 321315 0 0
Metabolic disorders
Surgery 321316 321316 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be given a solid meal consisting of 50g beef patty (584 kJ) that has been radiolabelled with 20 Mbq of technetium-99m sulphur colloid. The meal will be administered by a trained medical professional and will be consumed over 5 minutes at the research facility. The consumption of the solid meal will be supervised by the medical professional. Following this, gastric emptying data will be acquired in 1-min frames for the first 60 minutes, followed by 3-minute frames until t = 240 minutes. A region-of-interest that corresponds to the gastric pouch will be drawn to derive emptying curves and after 30 minutes, participants will be given a drink consisting of 150ml glucose (50g of glucose, 840kJ) containing 7 MBq gallium-67 EDTA which will include 3g 3-O-methylglucose (3-OMG, Sigma Aldrich USA). The time taken for 50% of the solid food to be emptied from the gastric pouch will be measured. 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] 321830 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329096 0
Time taken for 50% of the solid meal to empty from the gastric pouch assessed using gamma camera images following consumption of a solid meal containing 20 MBq of technetium-99m sulphur colloid.
Timepoint [1] 329096 0
Gastric pouch emptying image data will be acquired every minute for the first 60 minutes post-solid meal, then every 3 minutes until 240 minutes post-solid meal.
Secondary outcome [1] 401451 0
Plasma glucose concentrations
Timepoint [1] 401451 0
Glucose will be measured immediately before the test meal and at t = 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 min (t=0 is time of completion of solid test meal) .
Secondary outcome [2] 401452 0
Plasma concentrations of GLP-1 (glucagon-like peptide-1)
Timepoint [2] 401452 0
Immediately before the test meal and at t = 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 min post-solid test meal completion
Secondary outcome [3] 401453 0
Plasma concentrations of GIP (glucose dependent insulinotropic polypeptide)
Timepoint [3] 401453 0
Immediately before the test meal and at t = 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 min post-solid test meal completion
Secondary outcome [4] 401454 0
Plasma concentrations of insulin
Timepoint [4] 401454 0
Immediately before the test meal and at t = 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 min post-solid test meal completion
Secondary outcome [5] 401455 0
Plasma concentrations of C-peptide
Timepoint [5] 401455 0
Immediately before the test meal and at t = 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 min post-solid test meal completion
Secondary outcome [6] 401456 0
Plasma concentrations of glucagon
Timepoint [6] 401456 0
Immediately before the test meal and at t = 30, 60, 120, 180, 240 min post-solid test meal completion
Secondary outcome [7] 401457 0
Plasma concentrations of ghrelin
Timepoint [7] 401457 0
Immediately before the test meal and at t = 30, 60, 120, 180, 240 min post-solid test meal completion
Secondary outcome [8] 401458 0
Plasma concentrations of somatostatin
Timepoint [8] 401458 0
Immediately before the test meal and at t = 30, 60, 120, 180, 240 min post-solid test meal completion
Secondary outcome [9] 401459 0
Plasma concentrations of peptide YY 3-36 (PYY (3-36))
Timepoint [9] 401459 0
Immediately before the test meal and at t = 30, 60, 120, 180, 240 min post-solid test meal completion
Secondary outcome [10] 401460 0
Sigstad dumping score
Timepoint [10] 401460 0
Immediately before the test meal and at t=15, 30, 60, 90, 120, 150, 180, 210, 240 mi post-solid test meal completion
Secondary outcome [11] 401461 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] 401461 0
Immediately before the test meal and at t=15, 30, 60, 90, 120, 150, 180, 210, 240 min post-solid test meal completion
Secondary outcome [12] 401462 0
Fullness by visual analogue scale
Timepoint [12] 401462 0
Immediately before the test meal and at t=15, 30, 60, 90, 120, 150, 180, 210, 240 min post-solid test meal completion
Secondary outcome [13] 401463 0
Small intestinal glucose absorption measured by rate of absorption of the glucose analogue 3-OMG in a peripheral venous blood sample.
Timepoint [13] 401463 0
Measured at t=30, 60, 120, 180, 240 min post-solid test meal completion
Secondary outcome [14] 401464 0
Blood pressure measured using a sphygmomanometer
Timepoint [14] 401464 0
Measured immediately before test meal and then at 5 minute intervals until t = 240 min post-solid test meal completion
Secondary outcome [15] 401465 0
Heart rate measured using a pulse oximeter
Timepoint [15] 401465 0
Measured immediately before test meal and then at 5 minute intervals until t = 240 min post-solid test meal completion

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There are no prior studies of this nature. This is a proof of principle study. Participants will be recruited over a pre-specified 18 month timeframe. Data will be analysed using standardised, non-parametric or parametric statistical methods where appropriate (e.g. ANOVA). The analysis will be supervised by a professional biostatistician.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/12/2021
Actual
23/05/2022
Date of last participant enrolment
Anticipated
17/09/2024
Actual
Date of last data collection
Anticipated
17/09/2024
Actual
Sample size
Target
15
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 20639 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 20640 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 35428 0
5000 - Adelaide
Recruitment postcode(s) [2] 35429 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 309799 0
Government body
Name [1] 309799 0
National Health and Medical Research Council
Country [1] 309799 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] 310826 0
None
Name [1] 310826 0
None
Address [1] 310826 0
Not applicable
Country [1] 310826 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309546 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 309546 0
Ethics committee country [1] 309546 0
Australia
Date submitted for ethics approval [1] 309546 0
07/06/2021
Approval date [1] 309546 0
17/09/2021
Ethics approval number [1] 309546 0
2021/HRE00159

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

Contacts
Principal investigator
Name 114538 0
Prof Michael Horowitz
Address 114538 0
Level 5 Adelaide Health and Medical Science Building
4 North Terrace
Adelaide SA 5000
Country 114538 0
Australia
Phone 114538 0
+61870742673
Fax 114538 0
Email 114538 0
[email protected]
Contact person for public queries
Name 114539 0
Ryan Jalleh
Address 114539 0
Level 5 Adelaide Health and Medical Science Building
4 North Terrace
Adelaide SA 5000
Country 114539 0
Australia
Phone 114539 0
+61883131393
Fax 114539 0
Email 114539 0
[email protected]
Contact person for scientific queries
Name 114540 0
Ryan Jalleh
Address 114540 0
Level 5 Adelaide Health and Medical Science Building
4 North Terrace
Adelaide SA 5000
Country 114540 0
Australia
Phone 114540 0
+61883131393
Fax 114540 0
Email 114540 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.