Acarbose and Older Adults With Postprandial Hypotension

Phase 2

Completed

• Conditions: Other Specified Hypotension; Syncope
• Interventions: Drug: Acarbose; Drug: Placebo

• Registration Number: NCT01914133
• Lead Sponsor: Kenneth Madden

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

Study Timeline

• Study First Submitted: 2013-07-22
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-08-01
• Study Start: 2014-01
• Status Verified: 2021-05
• Primary Completion: 2021-05
• Study Completion: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Acarbose	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
The postprandial cardiovascular response to a standardized meal compared between subjects with and without PPH	2 years	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.

Secondary Outcome Measures

Name	Time	Method
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	2 years	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.	2.5 years	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.

Trial Locations

Locations (1)

Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186; 🇨🇦 Vancouver, British Columbia, Canada