Acarbose, Postprandial Hypotension and Type 2 Diabetes

NCT02043886 | Completed Phase 2

• 1 other identifier: H07-00510
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Postprandial Hypotension

Keywords

Type 2 Diabetes, Postprandial Hypotension, Acarbose

Outcome Measures

Primary Outcomes (7)

• 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)

Study Arms (2)

Acarbose

ACTIVE COMPARATOR

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

Drug: Acarbose

Placebo

PLACEBO COMPARATOR

Placebo 1 tablet at 0 minutes of Meal Test.

Drug: Placebo

Interventions

Acarbose DRUG

Acarbose 50 mg by mouth given during Meal Test

Also known as: Prandase, Precose

Acarbose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age 65 year and older
• Type 2 diabetes

You may not qualify if:

• less than 65 years of age

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Diabetes Association: collaborator

Study Sites (1)

VITALiTY Research Centre

Vancouver, British Columbia, V5Z1M9, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acarbose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Kenneth M Madden, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Study Start: June 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: May 1, 2014
• Last Updated: June 28, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)