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)

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000152224

Enrollment

Registered

2018-02-01

Start date

2011-01-14

Completion date

2017-12-06

Last updated

2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

65 Years to 80 Years

Healthy volunteers

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).

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

Outcome results