Acarbose and Older Adults With Postprandial Hypotension

Syncope Clinical Trial

— PPH  

Official title:

Acarbose and Older Adults With Postprandial Hypotension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914133
• Other study ID #: H13-01316
• Secondary ID: G-13-0001812
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: May 2021

Study information

• Verified date: May 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Other Specified Hypotension
• Syncope

Intervention

Drug:
• Acarbose
Acarbose 50 mg given during Meal Test and Acarbose 25 mg taken with first bite of the next 3 meals.
• Placebo
Placebo given prior to meal the standardized meal

Locations

Country	Name	City	State
Canada	Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Kenneth Madden

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ambulatory blood pressure monitoring (Welch-Allyn, Ambulatory Blood Pressure Monitor(ABPM) 6100S) performed for 24 hours	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.	1 day
Primary	The postprandial cardiovascular response to a standardized meal compared between subjects with and without PPH	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.	2 years
Secondary	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	The postprandial GLP-1 and GIP response to a standardized meal compared between subjects with and without PPH	2 years
Secondary	The postprandial cardiovascular response between the Acarbose group and the Placebo group will be compared.	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.	2.5 years