Skip to main content
OpenTrials
Completed

NCT Number: NCT02043886

Acarbose, Postprandial Hypotension and 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Postprandial Hypotension

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VITALiTY Research Centre

Vancouver, British Columbia, V5Z1M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 65 year and older
  • Type 2 diabetes

Exclusion criteria

  • less than 65 years of age

Treatment and study plan

Acarbose

Drug

Acarbose 50 mg by mouth given during Meal Test

Other names: Prandase, Precose

Placebo

Drug

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

Primary outcomes

  1. Heart rate

    Time frame: 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

  2. Blood pressure

    Time frame: Continuously during Meal Tests (approximately 4 hours)

    Blood pressure will be measured continuously by Finometer during each of the Meal Tests (approximately 4 hours)

  3. Middle cerebral artery velocity

    Time frame: 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)

  4. Serum glucose

    Time frame: Every 15 minutes during Meal Tests

    Serum glucose will be measured using a YSI (Yellow Spring Instruments) Stat 2300 Blood Glucose Analyzer

  5. Serum insulin

    Time frame: 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.

  6. Serum peptides: GIP (gastric inhibitory polypeptide) and GLP-1 (glucagon like peptide)

    Time frame: 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.

  7. Catecholamines

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Diabetes Association

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2014
First posted
Jan 23, 2014
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.