Acarbose, Postprandial Hypotension and Type 2 Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Postprandial Hypotension
• Intervention / Treatment: Drug: Acarbose; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • VITALiTY Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 65 year and older
• Type 2 diabetes

Exclusion Criteria:

• less than 65 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Canadian Diabetes Association
• Investigators: Principal Investigator: Kenneth M Madden, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Type 2 Diabetes, Postprandial Hypotension, Acarbose
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypotension; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Acarbose
• Other Study ID Numbers: H07-00510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No