The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes

This study has been completed.
Sponsor:
Collaborators:
American Diabetes Association
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Juraj Koska, Carl T. Hayden VA Medical Center
ClinicalTrials.gov Identifier:
NCT01181986
First received: August 13, 2010
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

The purpose of this investigation is to evaluate whether exenatide, a type 2 diabetes medication, will improve the function of the innermost part of the arterial wall called the endothelium after a fat-enriched meal and to determine how this occurs. The results of this study will help to determine and understand a novel action of this group of diabetes medications based on the action of naturally occuring gut substances called incretins. This may have a significant impact on cardiovascular health in patients with early and longstanding diabetes.


Condition Intervention
Type 2 Diabetes Mellitus
Drug: Exenatide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exenatide and Postprandial Endothelial Dysfunction: Effects and Mechanisms

Resource links provided by NLM:


Further study details as provided by Carl T. Hayden VA Medical Center:

Primary Outcome Measures:
  • Endothelial function [ Time Frame: Days 1 or 11 of intervention ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Postprandial endothelial dysfunction Drug: Exenatide
Exenatide 5-10 ug sc BID/10 days
Experimental: Fasting endothelial function Drug: Exenatide
Exenatide iv for 45 minutes

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • US Veterans
  • type 2 diabetes mellitus (T2D) diagnosed within 3 years with good glycemic control on diet, metformin, or sulfonylurea agents or combinations of these agents (HbA1c ≤8.0%)
  • T2D diagnosed ≥ 5 years prior to study enrollment
  • Impaired glucose tolerance

Exclusion Criteria:

  • T2D not meeting inclusion above criteria for duration of diabetes or HbA1c values
  • known or suspected T1D (early onset age, low body mass index, lack of family history)
  • TZD use in the prior 3 months
  • prior regular use of insulin
  • Creatinine >2.0 mg/dl or other laboratory or clinical evidence of kidney disease
  • anemia
  • known active liver disease or hepatic enzyme elevation two-and-a half times above normal
  • acute bacterial or viral illness or evidence of other active infection in the past 4 weeks
  • stable or unstable angina or other major illness in the past 6 months
  • Raynaud's disease or any rheumatic disease affecting fingers
  • current regular use of anti-inflammatory medications or antioxidants, including over the counter medications and high dose salicylates (>1 g/day);
  • subjects receiving lipid lowering or anti-hypertension medications must be on stable doses for at least 2 months prior to participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181986

Locations
United States, Arizona
Phoenix VA Medical Center
Phoenix, Arizona, United States, 85012
Sponsors and Collaborators
Carl T. Hayden VA Medical Center
American Diabetes Association
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: Juraj Koska, MD, PhD Phoenix VA Healthcare System
  More Information

No publications provided

Responsible Party: Juraj Koska, Research Health Scientist, Carl T. Hayden VA Medical Center
ClinicalTrials.gov Identifier: NCT01181986     History of Changes
Other Study ID Numbers: 1-10-CT-31
Study First Received: August 13, 2010
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Carl T. Hayden VA Medical Center:
Type 2 diabetes mellitus, Impaired glucose tolerance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014