Back to resultsMetabolic Causes of Thrombosis in Type 2 Diabetes - Question 1
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperinsulinemic Hyperglycemic Clamp
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Endothelial Function, Fibrinolytic Balance
Eligibility Criteria
Inclusion Criteria:
- 16 ( 8 female/ 8 male) Type 2 diabetic patients age 18-60 yrs
- 16 ( 8 female/ 8 male) Non-diabetic controls age and weight matched
- Body mass index 25-52 kgm2
- Female volunteers of childbearing potential: negative HCG pregnancy test
- Volunteers over 40 years old: normal baseline ECG
- For those with type 2 diabetes: HBA1C 6.5-10%
Exclusion Criteria:
- Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
- Uncontrolled hypertension
- History of cerebrovascular incidents
- Pregnancy
- Subjects unable to give voluntary informed consent
- Subjects with a recent medical illness
- Subjects with known liver or kidney disease
- Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
- Tobacco Use
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Endothelial function and fibrinolytic balance
Secondary Outcome Measures
Full Information
NCT ID
NCT00574665
First Posted
December 13, 2007
Last Updated
December 10, 2014
Sponsor
Vanderbilt University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00574665
Brief Title
Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 1
Official Title
SCCOR in Hemostatic and Thrombotic Diseases Project 5 - Metabolic Causes of Thrombosis in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to learn more about why patients with diabetes have increased heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood vessel. The proposed protocol will study the separate and combined effects of hyperglycemia and hyperinsulinemia on endothelial function and fibrinolytic balance in Type 2 DM. Our hypothesis is that hyperglycemia, rather than hyperinsulinemia, is responsible for the dysregulation of fibrinolytic balance in diabetics.
Detailed Description
This study will test the hypothesis that hyperglycemia will impair, while hyperinsulinemia will improve endothelial function and vascular fibrinolytic balance in type 2 DM. As discussed above, their roles in the increased prevalence of thrombotic events occurring in diabetics have not been defined. More recent data supports insulin as profibrinolytic and hyperglycemia to cause endothelial dysfunction. Conclusive studies are lacking in diabetic subjects. Furthermore, preliminary data from this lab indicates that in non-diabetic controls, hyperglycemia results in a prothrombotic state by increasing plasma PAI-1 and reducing tPA levels. The proposed protocol will study the separate and combined effects of hyperglycemia and hyperinsulinemia on endothelial function and fibrinolytic balance in Type 2 DM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes, Endothelial Function, Fibrinolytic Balance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Hyperinsulinemic Hyperglycemic Clamp
Intervention Description
Glucose Clamp
Primary Outcome Measure Information:
Title
Endothelial function and fibrinolytic balance
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
16 ( 8 female/ 8 male) Type 2 diabetic patients age 18-60 yrs
16 ( 8 female/ 8 male) Non-diabetic controls age and weight matched
Body mass index 25-52 kgm2
Female volunteers of childbearing potential: negative HCG pregnancy test
Volunteers over 40 years old: normal baseline ECG
For those with type 2 diabetes: HBA1C 6.5-10%
Exclusion Criteria:
Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
Uncontrolled hypertension
History of cerebrovascular incidents
Pregnancy
Subjects unable to give voluntary informed consent
Subjects with a recent medical illness
Subjects with known liver or kidney disease
Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
Tobacco Use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen N. Davis, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 1
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