Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000541000
Ethics application status
Approved
Date submitted
28/05/2010
Date registered
6/07/2010
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of posture and meal volume on gastric emptying and gut hormones after Roux-en-Y gastric bypass (RYGB)
Scientific title
Effects of posture and meal volume on gastric emptying, gut hormones, glycaemia, plasma insulin, haemodynamics, absorption, appetite, and gastrointestinal symptoms after gastric bypass
Secondary ID [1] 251880 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 257476 0
Condition category
Condition code
Oral and Gastrointestinal 257628 257628 0 0
Normal oral and gastrointestinal development and function
Diet and Nutrition 257668 257668 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Effects of posture and meal volume on gastric emptying, gut hormones, glycaemia, plasma insulin, haemodynamics, absorption, appetite, and gastrointestinal symptoms after gastric bypass.

Gastric emptying will be measured using scintigraphy for 4 hours directly after meal consumption
Gut hormones, glycaemia, plasma insulin and glucose absorption will be measured by taking blood samples at baseline (before meal consumption), and throughout the 4 hour duration of the study (after meal consumption) with the last sample taken at 240mins.
Appetite and gastrointestinal symptoms will be measured using questionnaires filled out at baseline and throughout the study with the last questionnaire filled out at the completion of the study (240mins)

Each subject will undergo concurrent measurements of gastric emptying, gut hormones, blood glucose, blood pressure, heart rate and gastrointestinal symptoms on 4 occasions, separated by at least 4 weeks in randomised order: (i) sitting & 50ml water/50g glucose; (ii) sitting & 200ml water/50g glucose; (iii) supine & 50ml water/50g glucose; and (iv) supine & 200ml water/50g glucose.
Intervention code [1] 256573 0
Other interventions
Comparator / control treatment
Each participant acts as their own control. Data comparisons in each individual are made to compare the different treatment groups
Control group
Active

Outcomes
Primary outcome [1] 258537 0
The primary outcome of this study is to determine the effect of meal volume and posture on the rate of gastric emptying in Roux-en-Y gastric bypass (RYGB) patients
Timepoint [1] 258537 0
This outcome will be measured on 4 separate occasions, separated by at least 4 weeks in randomised order (i) sitting & 50ml water/50g glucose; (ii) sitting & 200ml water/50g glucose; (iii) supine & 50ml water/50g glucose and (iv) supine & 200ml water/50g glucose. Gastric emptying will be measured directly after meal consumption using scintigraphy for the entire 4 hour duration of each study.
Primary outcome [2] 258538 0
Plasma concentrations of gut hormones (Cholecystokinin peptide YY, ghrelin, glucagon-like peptide-1 and insulin) and its correlation to the rate of gastric emptying.
Timepoint [2] 258538 0
intial baseline blood sample taken before meal consumption, then at 15, 30, 45, 60, 75, 90, 120, 150, 180, 240mins after meal consumption.
Primary outcome [3] 258737 0
Blood glucose concentrations and its correlation to the rate of gastric emptying.
Timepoint [3] 258737 0
Blood glucose concentrations will be immediately determined using a portable blood glucose meter at baseline prior to meal consumption, then at 15, 30, 45, 60, 75, 90, 120, 150, 180, 240mins after meal consumption.
Secondary outcome [1] 264378 0
Variations in blood pressure (BP) and heart rate (HR) and their correlations to the rate of gastric emptying.
Timepoint [1] 264378 0
BP (systolic and diastolic) and HR will also be measured with an automated oscillometric BP monitor (DINAMAP ProCare 100) at 3min intervals for the first 2 hours of the study and every 10mins for the remaining 2 hours of the study with the last timepoint at 240mins.
Secondary outcome [2] 264388 0
Gastrointestinal symptoms
Timepoint [2] 264388 0
Measured on physiological study days with a visual analogue scale (VAS) questionnaire. This questionnaire will be filled out at baseline before meal consumption and then at 15min intervals for the first 2 hours after meal consumption and every 30mins for the remaining 2hrs of the study. Last timepoint at 240mins.

Eligibility
Key inclusion criteria
Gastric bypass surgery at least 3 months prior to the intital physiological study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of severe respiratory, cardiovascular, hepatic and/or renal disease, chronic alcohol abuse or epilepsy
- Medication known to affect gastrointestinal function
- Diabetes mellitus requiring oral hypoglycaemic medication and/or insulin
- Exposure to ionising radiation for research purposes in the past 12 months
- Female patients not using appropriate contraceptive method
- Pregnant and/or breastfeeding mothers
- Smoking > 10 cigarettes/day
- Alcohol consumption > 20 g/day

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2010
Actual
15/07/2010
Date of last participant enrolment
Anticipated
Actual
13/10/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257069 0
Government body
Name [1] 257069 0
NH&MRC
Country [1] 257069 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 256327 0
None
Name [1] 256327 0
Address [1] 256327 0
Country [1] 256327 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259092 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 259092 0
Ethics committee country [1] 259092 0
Australia
Date submitted for ethics approval [1] 259092 0
Approval date [1] 259092 0
29/05/2009
Ethics approval number [1] 259092 0
090520

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

Contacts
Principal investigator
Name 31232 0
A/Prof Nam Q Nguyen
Address 31232 0
Department of Gastroenterology
Royal Adelaide Hospital
North Terrace, Adleaide SA 5000
Country 31232 0
Australia
Phone 31232 0
+61422113598
Fax 31232 0
Email 31232 0
[email protected]
Contact person for public queries
Name 14479 0
Tamara Debreceni
Address 14479 0
Department of Gastroenterology & Hepatology
Q7, Level 7, North Wing
North Terrace
Adelaide SA 5000
Country 14479 0
Australia
Phone 14479 0
+61 8 8222 5214
Fax 14479 0
+61 8 8222 5885
Email 14479 0
[email protected]
Contact person for scientific queries
Name 5407 0
Tamara Debreceni
Address 5407 0
Department of Gastroenterology & Hepatology
Q7, Level 7, North Wing
North Terrace
Adelaide SA 5000
Country 5407 0
Australia
Phone 5407 0
+61 8 8222 5214
Fax 5407 0
+61 8 8222 5885
Email 5407 0
[email protected]

No information has been provided regarding IPD availability


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.