Acarbose, Postprandial Hypotension and Type 2 Diabetes

Sponsor

University of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT02043886

Collaborator

Canadian Diabetes Association (Other)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Postprandial Hypotension	Drug: Acarbose Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Use of Acarbose to Treat Postprandial Hypotension in Older Adults With Type 2 Diabetes

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acarbose Acarbose 50mg by mouth at minute 0 of the Meal Test.	Drug: Acarbose Acarbose 50 mg by mouth given during Meal Test Other Names: Prandase, Precose
Placebo Comparator: Placebo Placebo 1 tablet at 0 minutes of Meal Test.	Drug: Placebo Non active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test.

Arm

Intervention/Treatment

Active Comparator: Acarbose

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

Drug: Acarbose

Acarbose 50 mg by mouth given during Meal Test

Other Names:

Prandase, Precose

Placebo Comparator: Placebo

Placebo 1 tablet at 0 minutes of Meal Test.

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Heart rate [continuously during Meal Test; about 4 hours]
Heart rate will be measured continuously by Finometer during the Meal Tests. Each Meal Test will take approximately 4 hours
Blood pressure [Continuously during Meal Tests (approximately 4 hours)]
Blood pressure will be measured continuously by Finometer during each of the Meal Tests (approximately 4 hours)
Middle cerebral artery velocity [continuously during Meal Tests (approximately 4 hours)]
Middle cerebral artery velocity will be measure continuously by transcranial doppler during the Meal Tests (approximately 4 hours)
Serum glucose [Every 15 minutes during Meal Tests]
Serum glucose will be measured using a YSI (Yellow Spring Instruments) Stat 2300 Blood Glucose Analyzer
Serum insulin [Every 15 minutes during Meal Tests (approximately 4 hours)]
Serum insulin levels will be collected every 15 minutes during the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.
Serum peptides: GIP (gastric inhibitory polypeptide) and GLP-1 (glucagon like peptide) [Every 15 minutes during Meal Tests (approximately 4 hours)]
Serum peptides will be collected every 15 minutes for the duration of the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.
Catecholamines [Continuously during Meal Test (approximately 4 hours)]
Serum insulin levels will be collected every 15 minutes during the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age 65 year and older
Type 2 diabetes

Exclusion Criteria:

less than 65 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VITALiTY Research Centre	Vancouver	British Columbia	Canada	V5Z1M9

Sponsors and Collaborators

University of British Columbia
Canadian Diabetes Association

Investigators

Principal Investigator: Kenneth M Madden, MD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kenneth Madden, Principal Investigator, University of British Columbia

ClinicalTrials.gov Identifier:

NCT02043886

Other Study ID Numbers:

H07-00510

First Posted:

Jan 23, 2014

Last Update Posted:

Jun 28, 2017

Last Verified:

Jun 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Kenneth Madden, Principal Investigator, University of British Columbia

Type 2 Diabetes, Postprandial Hypotension, Acarbose

Additional relevant MeSH terms:

Hypotension

Diabetes Mellitus

Diabetes Mellitus, Type 2

Acarbose

Study Results

No Results Posted as of Jun 28, 2017