Acarbose, Postprandial Hypotension and Type 2 Diabetes
NCT02043886 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2017-06-28
Summary
Postprandial hypotension carries a risk of significant morbidity and morbidity including syncope, falls, dizziness, fatigue, stroke and myocardial infarction. Current therapy consists of dietary manipulation (smaller meals) caffeine and octreotide injections all of which are suboptimal and poorly studied.
The study hypothesis is that administration of Acarbose will decrease the drop in blood pressure and increase in heart rate in response to food in people with Type 2 diabetes.
Acarbose suppresses postprandial glycemia be slowing digestion in the small intestine and delaying gastric emptying.
This is a placebo-controlled cross over study involving 2 - 4 hour Meal Tests. During the meal tests heart rate, blood pressure, cerebral artery velocity will be measured. During one meal test subjects will receive Acarbose 50 mg po and during the other will receive placebo. Order of treatment assignment will be done in randomized fashion. A total of approximately 200 cc of blood will be drawn during each meal test.
Conditions
- Type 2 Diabetes
- Postprandial Hypotension
Interventions
- DRUG
-
Acarbose
Acarbose 50 mg by mouth given during Meal Test
- DRUG
-
Non active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test.
Sponsors & Collaborators
-
Canadian Diabetes Association
collaborator OTHER -
University of British Columbia
lead OTHER
Principal Investigators
-
Kenneth M Madden, MD · University of British Columbia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2013-01-31
- Completion
- 2014-05-31
Countries
- Canada
Study Locations
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