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Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Stephen N. Davis, University of Maryland
ClinicalTrials.gov Identifier:
NCT00574340
First received: December 13, 2007
Last updated: February 9, 2017
Last verified: February 2017
December 13, 2007
February 9, 2017
May 2007
April 2011   (Final data collection date for primary outcome measure)
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.
Endothelial function and fibrinolytic balance [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00574340 on ClinicalTrials.gov Archive Site
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Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4
SCCOR in Hemostatic and Thrombotic Diseases Project 5 - Metabolic Causes of Thrombosis in Type 2 Diabetes
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.
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.
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant
Primary Purpose: Prevention
Type 2 Diabetes
Other: Hyperinsulinemic Hypoglycemic Clamp
all participants received (2) hyperinsulinemic glucose clamp studies separated by 8 weeks
  • 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
    Intervention: Other: Hyperinsulinemic Hypoglycemic Clamp
  • 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
    Intervention: Other: Hyperinsulinemic Hypoglycemic Clamp

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2011
April 2011   (Final data collection date for primary outcome measure)

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

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
 
 
NCT00574340
HP-00044875-SCCOR-Q4
RFAHL04016
Yes
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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