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Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829699
First Posted: January 27, 2009
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Stephen N. Davis, University of Maryland
January 23, 2009
January 27, 2009
February 10, 2017
July 2009
June 2013   (Final data collection date for primary outcome measure)
Percent change in flow mediated dilation of brachial artery [ Time Frame: 4 hours ]
Flow mediated dilation of brachial artery [ Time Frame: 4 hours ]
Complete list of historical versions of study NCT00829699 on ClinicalTrials.gov Archive Site
Change in Lipid measures [ Time Frame: 4hours ]
Lipid measures [ Time Frame: 4hours ]
Not Provided
Not Provided
 
Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus
Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus, Question 3
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.

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.

Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Type 2 Diabetes
  • Procedure: euinsulinemic euglycemic glucose clamp
    euinsulinemic euglycemic glucose clamp with lipid infusion 48 ml/hr for 4 hours
    Other Name: Intralipid
  • Procedure: euinsulinemic hyperglycemic glucose clamp
    euinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours
    Other Name: Intralipid
  • Procedure: Hyperinsulinemic euglycemic glucose clamp
    Hyperinsulinemic euglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours
    Other Name: Intralipid
  • Procedure: Hyperinsulinemic hyperglycemic glucose clamp
    Hyperinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours
    Other Name: Intralipid
  • Experimental: 1
    Euinsulinemic (low insulin infusion) Euglycemic (normal blood glucose levels) glucose clamp with lipid (fat) infusion
    Intervention: Procedure: euinsulinemic euglycemic glucose clamp
  • Experimental: 2
    Euinsulinemic Hyperglycemic (high glucose levels) glucose clamp with lipid infusion
    Intervention: Procedure: euinsulinemic hyperglycemic glucose clamp
  • Experimental: 3
    Hyperinsulinemic (High dose insulin) euglycemic glucose clamp with lipid infusion
    Intervention: Procedure: Hyperinsulinemic euglycemic glucose clamp
  • Experimental: 4
    Hyperinsulinemic hyperglycemic (high glucose level) glucose clamp with lipid infusion
    Intervention: Procedure: Hyperinsulinemic hyperglycemic glucose clamp
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
April 2014
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • 16 Type 2 diabetic patients age 18 - 60 yrs
  • 16 Non-diabetic controls age 18-60 yrs
  • Body mass index >20 kg/m2
  • Female volunteers of childbearing potential: negative urine pregnancy test
  • Volunteers over 40 years old: an ECG with no clinically significant conduction or ischemic changes.
  • For those with type 2 diabetes: HBA1C > 5.5%
  • For those with type 2 diabetes: C-peptide >0.2 nmol, If C-peptide is abnormal or there is a clinical suspicion for type 1 diabetes, MODY or LADA, anti-islet cell and anti-GAD antibodies will be assessed to establish the diagnosis of type 2 diabetes vs. type 1/LADA/MODY.
  • PT (time) 12.8-14.6 seconds, PTT (time) 25-38 seconds

Exclusion Criteria

  • Any current disease condition that alters carbohydrate metabolism (other than type 2 DM) and/or evidence for clinically significant cardiac disease
  • Uncontrolled hypertension
  • Pregnancy
  • Subjects unable to give voluntary informed consent
  • Subjects with history of pancreatitis
  • Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
  • Subjects with history of GI bleeding requiring treatment
  • Tobacco Use
  • Subjects with history of heparin-induced thrombocytopenia or heparin allergy
  • Subjects with severe egg or legume (soybean) allergy
  • Abnormal results following screening tests and physical examination that is clinically significant:

Medical history/Physical Exam Exclusion Criteria

  • Fever greater than 38 degrees C at screening or study initiation
  • Uncontrolled severe hypertension (i.e., blood pressure greater than 160/100)
  • Cardiac Abnormalities (e.g. Heart Failure, Arrhythmia, Cardiomyopathy, ischemic tachycardia, S-T segment deviations, etc.,) from history or ECG testing in subjects > 40 years old.
  • Diagnosed Pneumonia
  • Hepatic Failure/Jaundice
  • Clinically significant coagulopathy
  • Renal Failure
  • Acute Cerebrovascular/ Neurological deficit

Screening Laboratory Tests Exclusion Criteria according to protocol

Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00829699
HP-00044874
RFAHL04016
Yes
Not Provided
Not Provided
Stephen N. Davis, University of Maryland
University of Maryland
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Stephen N. Davis, MD University of Maryland
University of Maryland
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP