Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus

Early Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Procedure: Hyperinsulinemic hyperglycemic glucose clamp; Procedure: euinsulinemic hyperglycemic glucose clamp; Procedure: euinsulinemic euglycemic glucose clamp; Procedure: Hyperinsulinemic euglycemic glucose clamp

• Registration Number: NCT00829699
• Lead Sponsor: University of Maryland, Baltimore

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 high glucose and high fats on certain cardiovascular responses in Type 2 DM.

Detailed Description

Currently 75-80% of diabetes mellitus (DM) patients die due to thrombotic causes. Data from the Centers for Disease Control and Prevention released in 2000 indicated that mortality due to coronary artery disease is decreasing except in individuals with diabetes. Clearly the disordered metabolism, which includes abnormal metabolism of fats resulting in higher triglyceride and free fatty acid blood levels, occurring in diabetes predisposes these individuals to increased thrombotic events. Unless the underlying mechanisms responsible for these events can be identified, there will be an unprecedented number of diabetic patients suffering thrombotic episodes in the next 10 years.

The specific aims of this study are to determine the effects of elevated free fatty acids and hyperglycemia (high glucose)on endothelial function and thrombolytic balance in patients with type 2 diabetes, and to determine the effects of increased insulin in this setting.

Study Timeline

• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Study Start: 2009-07
• Primary Completion: 2013-06
• Study Completion: 2014-04
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
4	Hyperinsulinemic hyperglycemic glucose clamp	Hyperinsulinemic hyperglycemic (high glucose level) glucose clamp with lipid infusion
2	euinsulinemic hyperglycemic glucose clamp	Euinsulinemic Hyperglycemic (high glucose levels) glucose clamp with lipid infusion
1	euinsulinemic euglycemic glucose clamp	Euinsulinemic (low insulin infusion) Euglycemic (normal blood glucose levels) glucose clamp with lipid (fat) infusion
3	Hyperinsulinemic euglycemic glucose clamp	Hyperinsulinemic (High dose insulin) euglycemic glucose clamp with lipid infusion

Primary Outcome Measures

Name	Time	Method
Percent change in flow mediated dilation of brachial artery	4 hours

Secondary Outcome Measures

Name	Time	Method
Change in Lipid measures	4hours

Trial Locations

Locations (1)

Univerisity of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States