Acarbose, Postprandial Hypotension and Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes; Postprandial Hypotension
• Interventions: Drug: Placebo; Drug: Acarbose

• Registration Number: NCT02043886
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2013-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-23
• Study Completion: 2014-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• age 65 year and older
• Type 2 diabetes

Exclusion Criteria

• less than 65 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 1 tablet at 0 minutes of Meal Test.
Acarbose	Acarbose	Acarbose 50mg by mouth at minute 0 of the Meal Test.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

VITALiTY Research Centre; 🇨🇦 Vancouver, British Columbia, Canada