Acarbose and Older Adults With Postprandial Hypotension (PPH)
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.
Other Specified Hypotension
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Acarbose and Older Adults With Postprandial Hypotension|
- The postprandial cardiovascular response to a standardized meal compared between subjects with and without PPH [ Time Frame: 2 years ] [ Designated as safety issue: No ]The postprandial cardiovascular response (mesenteric blood flow, adrenergic response, cerebral blood flow) to a standardized meal will be compared between n=30 subjects with PPH and n= 30 subjects without PPH.
- 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]The postprandial GLP-1 and GIP response to a standardized meal compared between subjects with and without PPH
- The postprandial cardiovascular response between the Acarbose group and the Placebo group will be compared. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]The postprandial cardiovascular response (mesenteric blood flow, adrenergic response, cerebral blood flow) to a standardized meal between the Acarbose group and the Placebo group will be compared.
- ambulatory blood pressure monitoring (Welch-Allyn, Ambulatory Blood Pressure Monitor(ABPM) 6100S) performed for 24 hours [ Time Frame: 1 day ] [ Designated as safety issue: No ]Starting the day following each meal test, each subject with PPH will take either acarbose 25 mg po tid (prior to each meal) or placebo po tid for one day. During this 24 hour period, each subject will undergo 24 Hr-ABPM (starting at 7 ante meridian (AM) the following day). Each subject will have ambulatory blood pressure monitoring (Welch-Allyn, ABPM 6100S) performed for 24 hours. Each subject will carry a logbook to record time of activity and all meals. Each subject will be given a watch synchronized to the 24-hour blood pressure monitor.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
No Intervention: No Postprandial Hypotension (PPH)
Screening Meal Test performed and subject does not meet criteria for Postprandial Hypotension (PPH).
Placebo Comparator: Placebo
Screening Meal Test performed and subject meets criteria for Postprandial Hypotension (PPH). At second Meal Test subject will receive a placebo and will take a placebo with the first bite of the next 3 meals.
Placebo given prior to meal the standardized meal
Active Comparator: Acarbose
Screening Meal Test performed and subject meets criteria for Postprandial Hypotension. During the second Meal Test subject will receive Acarbose 50mg and will take Acarbose 25mg with first bite of each of the next 3 meals.
Acarbose 50 mg given during Meal Test and Acarbose 25 mg taken with first bite of the next 3 meals.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01914133
|Contact: Gale R Tedder, RN, BSNfirstname.lastname@example.org|
|Canada, British Columbia|
|Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Contact: Gale Tedder, RN, BSN 604-875-5115 email@example.com|
|Principal Investigator: Kenneth M Madden, MD MSc FRCPC|
|Sub-Investigator: Graydon Meneilly, MD, FRCPC|
|Principal Investigator:||Kenneth M Madden, MD||University of British Columbia|