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Trial registered on ANZCTR


Registration number
ACTRN12618000152224
Ethics application status
Approved
Date submitted
23/01/2018
Date registered
1/02/2018
Date last updated
1/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
What are the individual and combined effects of water drinking and Acarbose (a medication which blocks the breakdown of sugar in the small intestine) on the fall in blood pressure after a sugar drink, in volunteers who are known to have postprandial hypotension (a significant fall in blood pressure that occurs after eating)
Scientific title
The effects of gastric distension and acarbose on the blood pressure, heart rate, gastric emptying and splanchnic blood flow responses to oral sucrose in patients with postprandial hypotension.
Secondary ID [1] 293869 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial Hypotension 306332 0
Condition category
Condition code
Cardiovascular 305418 305418 0 0
Other cardiovascular diseases
Oral and Gastrointestinal 305469 305469 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be studied on 4 separate occasions at least five days apart. On each occasion, after an overnight fast (solids for 14 h and liquids for 12 h), subjects will receive one of the following drinks:
1) 100g sucrose dissolved in 300ml of water
2) 300ml water preload 15 minutes before the ingestion of a drink comprising of 100g sucrose dissolved in 300ml of water
3) 100g sucrose with 100mg acarbose (Glucobay) dissolved in 300ml of water
4) 300ml water preload 15 minutes before the ingestion of a drink comprising of 100g sucrose with 100mg acarbose dissolved in 300ml of water
The order of the drinks will be randomized, and subjects will be blinded regarding the presence of acarbose. The subject will be asked to consume the drinks within 3 minutes. All interventions will be prepared by appropriately qualified and experienced research staff.
Intervention code [1] 300129 0
Treatment: Drugs
Intervention code [2] 300130 0
Prevention
Comparator / control treatment
The drink comprising 100g sucrose dissolved in 300ml of water serves as the control for each subject
Control group
Active

Outcomes
Primary outcome [1] 304551 0
Change in blood pressure measured with automated BP cuff (DINAMAP ProCare 100, GE Medical Systems, Milwaukee, WI, USA)
Timepoint [1] 304551 0
Blood pressure was assessed at 3 minute intervals for 10 minutes prior to consumption of the drink, then at 3 minute intervals for 2 hours (i.e. between t= 0 - 120 min) and at 15 minute intervals for a further 2 hours (i.e. between t= 120 - 240).
Secondary outcome [1] 342362 0
Change in heart rate measured with automated BP cuff (DINAMAP ProCare 100, GE Medical Systems, Milwaukee, WI, USA).
Timepoint [1] 342362 0
Heart rate was assessed at 3 minute intervals for 10 minutes prior to consumption of the drink, then at 3 minute intervals for 2 hours (i.e. between t= 0 - 120 min) and at 15 minute intervals for a further 2 hours (i.e. between t= 120 - 240).
Secondary outcome [2] 342363 0
Gastric emptying assessed by 3D ultrasound using a Logiq 9 ultrasound system (GE Medical Systems)
Timepoint [2] 342363 0
Gastric emptying acquisition commenced before ingestion of the water preload (t = -20 minutes) or drink (t = -2 minutes). Further images were obtained every 15 minutes after ingestion for 4 hours (i.e. between t= 0 - 240 min).
Secondary outcome [3] 342365 0
Superior mesenteric artery (SMA) blood flow assessed by Doppler ultrasonography using a Logiq 9 ultrasound system (GE Medical Systems)
Timepoint [3] 342365 0
SMA blood flow measurements commenced before ingestion of the water preload (t = -20 minutes) or drink (t = -2 minutes). Further measurements were obtained every 15 minutes after ingestion for 4 hours (i.e. between t= 0 - 240 min).
Secondary outcome [4] 342366 0
Sensations of appetite measured with a visual analogue scale
Timepoint [4] 342366 0
Questionnaires were given immediately prior to the ingestion of the water preload (t = -20 minutes) and/or drink (t = -2 minutes) then again at t= 30, 60, 90. 120. 180 and 240 min.
Secondary outcome [5] 342367 0
Blood glucose measured with a portable glucometer on blood samples (~17ml) collected from an IV cannula
Timepoint [5] 342367 0
Blood samples were collected immediately prior to the ingestion of the water preload (t = -20 minutes) and/or drink (t = -2 minutes) then again at t= 30, 60, 90. 120. 180 and 240 min.
Secondary outcome [6] 342368 0
Insulin using serum samples
Timepoint [6] 342368 0
Insulin is measured immediately prior to the ingestion of the water preload (t = -20 minutes) and/or drink (t = -2 minutes) then again at t= 30, 60, 90. 120. 180 and 240 min.
Secondary outcome [7] 342530 0
Glucagon-like peptide 1 (GLP-1) using plasma samples
Timepoint [7] 342530 0
GLP-1 is measured immediately prior to the ingestion of the water preload (t = -20 minutes) and/or drink (t = -2 minutes) then again at t= 30, 60, 90. 120. 180 and 240 min.
Secondary outcome [8] 342531 0
Gastric inhibitory polypeptide (GIP) using plasma samples
Timepoint [8] 342531 0
GIP is measured immediately prior to the ingestion of the water preload (t = -20 minutes) and/or drink (t = -2 minutes) then again at t= 30, 60, 90. 120. 180 and 240 min.

Eligibility
Key inclusion criteria
Subjects who have postprandial hypotension (defined as a fall in systolic blood pressure greater than or equal to 20mmHg, occurring within two hours of the end of a meal).
Minimum age
65 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI <19 or >30 kg/m²
Abnormal biochemistry (LFTs/Iron studies) at screening prior to enrollment
History of diabetes mellitus
Severe respiratory, cardiovascular, hepatic and/or renal disease (creatinine clearance <50 mL/min),
Chronic alcohol abuse or smoking >10 cigarettes/day
Epilepsy
Blood donation in the previous 12 weeks

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Online randomisation program (random.org).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data will be analysed using standardised, non-parametric statistical methods (e.g. using repeated measures ANOVA). Relationships between variables will be assessed by linear regression analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9861 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 18646 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 298487 0
Government body
Name [1] 298487 0
National Health and Medical Research Council of Australia
Address [1] 298487 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 298487 0
Australia
Primary sponsor type
Individual
Name
Professor Karen Jones
Address
The University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building
Cnr North Tce and George St
Adelaide, SA 5005
Country
Australia
Secondary sponsor category [1] 297629 0
None
Name [1] 297629 0
Address [1] 297629 0
Country [1] 297629 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299474 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 299474 0
North Terrace
Adelaide SA 5000
Ethics committee country [1] 299474 0
Australia
Date submitted for ethics approval [1] 299474 0
Approval date [1] 299474 0
26/11/2010
Ethics approval number [1] 299474 0
091228

Summary
Brief summary
To determine in patients with postprandial hypotension (defined as a fall in systolic blood pressure >20mmHg within 2 hours of a meal) whether the magnitude of the fall in blood pressure and rises in heart rate and blood flow to the stomach in response to a drink of sugar (sucrose) are attenuated by both acarbose (an anti-diabetic drug which blocks the breakdown of sugar in the intestine, preventing its absorption) and gastric distension (by drinking a small volume of water) and if these effects are additive. We hypothesise that both gastric distension and acarbose will attenuate the fall in blood pressure, and these effects will be additive.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80530 0
Prof Karen Jones
Address 80530 0
The University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building
Cnr North Tce and George St
Adelaide, SA 5005
Country 80530 0
Australia
Phone 80530 0
+61-8-8313 7821
Fax 80530 0
Email 80530 0
karen.jones@adelaide.edu.au
Contact person for public queries
Name 80531 0
Prof Karen Jones
Address 80531 0
The University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building
Cnr North Tce and George St
Adelaide, SA 5005
Country 80531 0
Australia
Phone 80531 0
+61-8-8313 7821
Fax 80531 0
Email 80531 0
karen.jones@adelaide.edu.au
Contact person for scientific queries
Name 80532 0
Prof Karen Jones
Address 80532 0
The University of Adelaide
Level 5 Adelaide Health and Medical Sciences Building
Cnr North Tce and George St
Adelaide, SA 5005
Country 80532 0
Australia
Phone 80532 0
+61-8-8313 7821
Fax 80532 0
Email 80532 0
karen.jones@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary