Clinical trial NCT01914133: Acarbose and Older Adults With Postprandial Hypotension
Official title: Acarbose and Older Adults With Postprandial Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Other Specified Hypotension
Syncope
Keywords: Acarbose
PPH (Post Prandial Hypotension)
Falls
Syncope
Elderly
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The current proposal will determine if blocking carbohydrate intake in the small intestine with Acarbose can be a possible therapy for older adults with (PPH) Post Prandial Hypotension (a drop of blood pressure after eating), which can result in falls.

Detailed description: Blocking the absorption of carbohydrates at the brush border of the small intestine with acarbose (an alpha-glucosidase inhibitor) seems a promising possibility as a potential therapeutic agent. Although designed as a second-line diabetes drug, this medication has very little risk of hypoglycemia in older adults. In fact the risk of hypoglycemia is extremely low even in patients concurrently taking concurrent hypoglycemia agents (including insulin), and there is almost no risk of hypoglycemia in subjects not on other diabetes medications. Acarbose suppresses postprandial glycemia by slowing small intestinal digestion and absorption of carbohydrate, and has been shown to slow gastric emptying Acarbose has yet to be examined in a prospective fashion in older adults, despite the prevalence of PPH in this patient population. Preliminary, pilot work done in our laboratory on older adults with PPH has demonstrated that the hypotensive response over 90 minutes to a standardized meal was significantly reduced by the administration of acarbose

Eligibility criteria: Inclusion Criteria:

* be 65 years of age or older,
* be a non-smoker for at least 5 years
* be referred to the falls clinic at Vancouver General Hospital
* have a Folstein test of cognition \> 25/30 to ensure meal log-book compliance

Exclusion Criteria:

* no oral or swallowing issues that would prevent a Meal Test
* subject requiring dialysis due to end-stage renal failure will be excluded
* subjects with evidence on history, physical or blood work of hepatic disease will be excluded since elevated serum transaminases are a potential adverse effect of acarbose
* cannot currently be taking an alpha-glucosidase inhibitor
* cannot have had allergic reactions to alpha-glucosidase inhibitors in the past
* Due to the fact that acarbose is renally excreted, all subjects must have a Creatine Clearance of greater than 25 ml/min
* Subjects with a past history of inflammatory bowel disease, intestinal obstruction, ileus and peptic ulcer disease will be excluded
* Subjects taking carbohydrate-splitting enzymes (such as amylase) will be excluded
* Subjects with chronic respiratory issues requiring treatment will be excluded

Primary outcomes:
measure: The postprandial cardiovascular response to a standardized meal compared between subjects with and without PPH
timeFrame: 2 years
Secondary outcomes:
measure: The postprandial glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP) response to a standardized meal compared between subjects with and without PPH
timeFrame: 2 years
measure: The postprandial cardiovascular response between the Acarbose group and the Placebo group will be compared.
timeFrame: 2.5 years
Other outcomes:
measure: ambulatory blood pressure monitoring (Welch-Allyn, Ambulatory Blood Pressure Monitor(ABPM) 6100S) performed for 24 hours
timeFrame: 1 day
Locations:
city: Vancouver
country: Canada
facility: Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kenneth M Madden, MD
role: PRINCIPAL_INVESTIGATOR
References: