Acarbose, Postprandial Hypotension and Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02043886
First received: January 21, 2014
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Type 2 Diabetes
Postprandial Hypotension
Drug: Acarbose
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Acarbose to Treat Postprandial Hypotension in Older Adults With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Heart rate [ Time Frame: continuously during Meal Test; about 4 hours ] [ Designated as safety issue: No ]
    Heart rate will be measured continuously by Finometer during the Meal Tests. Each Meal Test will take approximately 4 hours

  • Blood pressure [ Time Frame: Continuously during Meal Tests (approximately 4 hours) ] [ Designated as safety issue: No ]
    Blood pressure will be measured continuously by Finometer during each of the Meal Tests (approximately 4 hours)

  • Middle cerebral artery velocity [ Time Frame: continuously during Meal Tests (approximately 4 hours) ] [ Designated as safety issue: No ]
    Middle cerebral artery velocity will be measure continuously by transcranial doppler during the Meal Tests (approximately 4 hours)

  • Serum glucose [ Time Frame: Every 15 minutes during Meal Tests ] [ Designated as safety issue: No ]
    Serum glucose will be measured using a YSI (Yellow Spring Instruments) Stat 2300 Blood Glucose Analyzer

  • Serum insulin [ Time Frame: Every 15 minutes during Meal Tests (approximately 4 hours) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Every 15 minutes during Meal Tests (approximately 4 hours) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Continuously during Meal Test (approximately 4 hours) ] [ Designated as safety issue: No ]
    Serum insulin levels will be collected every 15 minutes during the Meal Tests (approximately 4 hours) and analyzed by Elisa (enzyme linked immunoabsorbant) assays.


Enrollment: 15
Study Start Date: June 2007
Study Completion Date: May 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 65 year and older
  • Type 2 diabetes

Exclusion Criteria:

  • less than 65 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043886

Locations
Canada, British Columbia
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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02043886     History of Changes
Other Study ID Numbers: H07-00510
Study First Received: January 21, 2014
Last Updated: July 15, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Type 2 Diabetes, Postprandial Hypotension, Acarbose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypotension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Acarbose
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014