Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus

September 10, 2019 updated by: Stephen N. Davis, MBBS, University of Maryland, Baltimore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Univerisity of Maryland, Baltimore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Euinsulinemic (low insulin infusion) Euglycemic (normal blood glucose levels) glucose clamp with lipid (fat) infusion
Procedure: euinsulinemic euglycemic glucose clamp
euinsulinemic euglycemic glucose clamp with lipid infusion 48 ml/hr for 4 hours
Other Names:
  • Intralipid
Experimental: 2
Euinsulinemic Hyperglycemic (high glucose levels) glucose clamp with lipid infusion
Procedure: euinsulinemic hyperglycemic glucose clamp
euinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours
Other Names:
  • Intralipid
Experimental: 3
Hyperinsulinemic (High dose insulin) euglycemic glucose clamp with lipid infusion
Procedure: Hyperinsulinemic euglycemic glucose clamp
Hyperinsulinemic euglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours
Other Names:
  • Intralipid
Experimental: 4
Hyperinsulinemic hyperglycemic (high glucose level) glucose clamp with lipid infusion
Procedure: Hyperinsulinemic hyperglycemic glucose clamp
Hyperinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours
Other Names:
  • Intralipid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in flow mediated dilation of brachial artery
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Lipid measures
Time Frame: 4hours
4hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (Estimate)

January 27, 2009

Study Record Updates

Last Update Posted (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00044874
  • RFAHL04016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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