The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes
This study has been completed.
Sponsor:
Carl T. Hayden VA Medical Center
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
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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 May 22, 2013