Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4

This study is currently recruiting participants.

Verified by Vanderbilt University, June 2009

First Received: December 13, 2007 Last Updated: June 23, 2009 History of Changes

Sponsors and Collaborators:	Vanderbilt University National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00574340

Purpose

Hypoglycemia 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 antecedent hypoglycemia will result in a prothrombotic state and reduced endothelial function during subsequent hypoglycemia.

Condition	Intervention
Type 2 Diabetes	Other: Hyperinsulinemic Hypoglycemic Clamp

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Factorial Assignment
Official Title:	SCCOR in Hemostatic and Thrombotic Diseases Project 5 - Metabolic Causes of Thrombosis in Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Hypoglycemia

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Endothelial function and fibrinolytic balance [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	May 2007
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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. My 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 25-52 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 greater than 6.0%

Exclusion Criteria:

Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
Uncontrolled hypertension
History of cerebrovascular incidents
Abnormal results following screening tests and physical examination
Pregnancy
Subjects unable to give voluntary informed consent
Subjects with a recent medical illness
Subjects taking thiazolidinediones
Subjects with known liver or kidney disease
Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
Tobacco Use

Contacts and Locations

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

Contacts

Contact: Nino Gogitidze, MD

615-936-1824

nino.gogitidze@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Donna B. Tate, MS 615-936-1824 donna.tate@vanderbilt.edu
Principal Investigator: Stephen N. Davis, MD

Sponsors and Collaborators

Vanderbilt University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Stephen N. Davis, MD

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University ( Stephen N. Davis, MD )
Study ID Numbers:	IRB#070163-SCCOR-Q4, RFAHL04016
Study First Received:	December 13, 2007
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00574340 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Type 2 Diabetes
Endothelial Function
Fibrinolytic Balance
Hypoglycemia

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Hypoglycemia
Thrombosis
Hemostatics

Embolism and Thrombosis
Hypoglycemic Agents
Embolism
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Embolism and Thrombosis
Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Vascular Diseases

Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Thrombosis

ClinicalTrials.gov processed this record on September 11, 2009