Acarbose and Older Adults With Postprandial Hypotension

Study Overview
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Brief Summary
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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
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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

Official Title
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Acarbose and Older Adults With Postprandial Hypotension

Conditions
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Syncope, Other Specified Hypotension

Intervention / Treatment
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* Drug: Acarbose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Postprandial Hypotension (PPH)<br>Screening Meal Test performed and subject does not meet criteria for Postprandial Hypotension (PPH). | |
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* Placebo given prior to meal the standardized meal<br>* Other names: Acarbose Placebo Tablet;|
| Active Comparator: Acarbose<br>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. | Drug: Acarbose<br>* Acarbose 50 mg given during Meal Test and Acarbose 25 mg taken with first bite of the next 3 meals.<br>* Other names: Alpha-glucosidase inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acarbose, PPH (Post Prandial Hypotension), Falls, Syncope, Elderly