Acarbose, Postprandial Hypotension and Type 2 Diabetes

NCT ID: NCT02043886

Last Updated: 2017-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Postprandial Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Acarbose

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

Group Type ACTIVE_COMPARATOR

Acarbose

Intervention Type DRUG

Acarbose 50 mg by mouth given during Meal Test

Placebo

Placebo 1 tablet at 0 minutes of Meal Test.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Non active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test.

Interventions

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Acarbose

Acarbose 50 mg by mouth given during Meal Test

Intervention Type DRUG

Placebo

Non active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test.

Intervention Type DRUG

Other Intervention Names

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Prandase, Precose

Eligibility Criteria

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Inclusion Criteria

* age 65 year and older
* Type 2 diabetes

Exclusion Criteria

* less than 65 years of age
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Diabetes Association

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Madden

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth M Madden, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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VITALiTY Research Centre

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H07-00510

Identifier Type: -

Identifier Source: org_study_id

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