Acarbose, Postprandial Hypotension and Type 2 Diabetes

University of British Columbia

Status and phase: Completed; Phase 2

Conditions: Postprandial Hypotension; Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Acarbose

Study type: Interventional

Funder types: Other

Identifiers

NCT02043886

H07-00510

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 65 year and older
• Type 2 diabetes

Exclusion criteria

• less than 65 years of age

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

Acarbose

Active Comparator group

Description:

Acarbose 50mg by mouth at minute 0 of the Meal Test.

Treatment:

Drug: Acarbose

Placebo

Placebo Comparator group

Description:

Placebo 1 tablet at 0 minutes of Meal Test.

Treatment:

Drug: Placebo