Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen N. Davis, University of Maryland
ClinicalTrials.gov Identifier:
NCT00574340
First received: December 13, 2007
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

Hypoglycemia (low blood glucose level) occurs frequently in intensively treated patients with diabetes. Although hypoglycemia was thought to occur almost exclusively in T1DM, with the advent of improved metabolic control in T2DM, the incidence of hypoglycemia is rising in these patients. Therefore in this application, we will test the novel hypothesis that prior hypoglycemia will result in (cardiovascular complications) during subsequent hypoglycemia.


Condition Intervention
Type 2 Diabetes
Other: Hyperinsulinemic Hypoglycemic Clamp

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: SCCOR in Hemostatic and Thrombotic Diseases Project 5 - Metabolic Causes of Thrombosis in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    A measure of the baseline arterial dilation is compared to the post intervention measure of dilation of the brachial artery.


Enrollment: 28
Study Start Date: May 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glucose clamp
Day 1 euglycemia, day 2 hypoglycemia
Other: Hyperinsulinemic Hypoglycemic Clamp
hyperinsulinemic glucose clamp separated by 8 weeks

Detailed Description:

This study will test the hypothesis that 1) hypoglycemia causes a prothrombotic state and defective endothelial function and 2) episodes of repeated hypoglycemia will result in greater impairments of endothelial function and an increased prothrombotic tendency. Preliminary data in healthy men demonstrates that hypoglycemia can dramatically increase PAI-1 levels and the PAI-1 to tPA ratio, thereby creating a prothrombotic state. Whether this also occurs in type 2 DM patients is unknown. Furthermore, the effects of hypoglycemia on endothelial function in T2DM are also unknown.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 >20 kg/m2
  • Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities
  • Female volunteers of childbearing potential: negative HCG pregnancy test
  • Volunteers over 40 years old: normal baseline cardiac stress test
  • For those with type 2 diabetes: HBA1C >5.5%
  • For those with type 2 diabetes: diabetes < 20 years
  • For those with type 2 diabetes: C-peptide >0.2 nmol (1.1-4.4 ng/ml). If c-peptide is abnormal or there is a clinical suspicion of type 1 diabetes, MODY, or LADA, Anti-Islet cell (negative) and Glutamic Acid Decarboxylase (GAD) antibody negative (0.0-1.5 U/ml) will be performed

Exclusion Criteria

  • Uncontrolled hypertension
  • History of cerebrovascular incidents
  • Pregnancy
  • Subjects unable to give voluntary informed consent
  • Subjects with a recent medical illness
  • Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
  • Tobacco Use

Physical Exam Exclusion Criteria

  • Blood Pressure greater than 150/95
  • Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmias, ischemic tachycardia, S-T segment deviations, ect.) from history or from cardiac stress testing
  • Pneumonia
  • Hepatic Failure/Jaundice
  • Renal Failure
  • Acute Cerebrovascular/ Neurological deficit
  • Fever greater than 38.0 C

Screening blood tests exclusions according to protocol

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574340

Locations
United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Stephen N. Davis, MD University of Maryland, Baltimore County
  More Information

No publications provided by University of Maryland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen N. Davis, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT00574340     History of Changes
Other Study ID Numbers: HP-00044875-SCCOR-Q4, RFAHL04016
Study First Received: December 13, 2007
Results First Received: May 27, 2014
Last Updated: August 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Type 2 Diabetes
Endothelial Function
Fibrinolytic Balance
Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Thrombosis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014