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Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00574340
First Posted: December 17, 2007
Last Update Posted: March 29, 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
  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 Phase
Type 2 Diabetes Other: Hyperinsulinemic Hypoglycemic Clamp Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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 Stephen N. Davis, University of Maryland:

Primary Outcome Measures:
  • Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound on Day 2 [ Time Frame: baseline on day 2 and ~6 hours later at end of glucose clamp period ]
    A measure of the baseline arterial dilation on day 2 is compared to the post intervention measure of dilation of the brachial artery on Day 2.


Enrollment: 20
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
Active Comparator: Control study then antecedent hypoglycemia study group
Day 1 euglycemia, day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to antecedent hypoglycemia study Day 1 hypoglycemia, Day 2 hypoglycemia
Other: Hyperinsulinemic Hypoglycemic Clamp
all participants received (2) hyperinsulinemic glucose clamp studies separated by 8 weeks
Active Comparator: Antecedent Hypoglycemic clamp study
Day 1 hypoglycemia, day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to control study Day 1 euglycemia, Day 2 hypoglycemia
Other: Hyperinsulinemic Hypoglycemic Clamp
all participants received (2) hyperinsulinemic glucose clamp studies 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • 14 (7 female/ 7 male) Type 2 diabetic patients age 18-60 yrs
  • 14 (7 female/ 7 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574340


Locations
United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Stephen N. Davis, MD University of Maryland
  More Information

Publications:
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
First Submitted: December 13, 2007
First Posted: December 17, 2007
Results First Submitted: May 27, 2014
Results First Posted: September 1, 2014
Last Update Posted: March 29, 2017
Last Verified: February 2017

Keywords provided by Stephen N. Davis, University of Maryland:
Type 2 Diabetes
Endothelial Function
Fibrinolytic Balance
Hypoglycemia

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