Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus

NCT00829699 | Completed Early Phase 1 DMC

• 2 other identifiers: HP-00044874RFAHL04016
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

endothelial function; fibrinolytic balance

Outcome Measures

Primary Outcomes (1)

• Percent change in flow mediated dilation of brachial artery

  4 hours

Secondary Outcomes (1)

• Change in Lipid measures

  4hours

Study Arms (4)

1

EXPERIMENTAL

Euinsulinemic (low insulin infusion) Euglycemic (normal blood glucose levels) glucose clamp with lipid (fat) infusion

Procedure: euinsulinemic euglycemic glucose clamp

2

EXPERIMENTAL

Euinsulinemic Hyperglycemic (high glucose levels) glucose clamp with lipid infusion

Procedure: euinsulinemic hyperglycemic glucose clamp

3

EXPERIMENTAL

Hyperinsulinemic (High dose insulin) euglycemic glucose clamp with lipid infusion

Procedure: Hyperinsulinemic euglycemic glucose clamp

4

EXPERIMENTAL

Hyperinsulinemic hyperglycemic (high glucose level) glucose clamp with lipid infusion

Procedure: Hyperinsulinemic hyperglycemic glucose clamp

Interventions

euinsulinemic euglycemic glucose clamp PROCEDURE

euinsulinemic euglycemic glucose clamp with lipid infusion 48 ml/hr for 4 hours

Also known as: Intralipid

1

euinsulinemic hyperglycemic glucose clamp PROCEDURE

euinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours

Also known as: Intralipid

2

Hyperinsulinemic euglycemic glucose clamp PROCEDURE

Hyperinsulinemic euglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours

Also known as: Intralipid

3

Hyperinsulinemic hyperglycemic glucose clamp PROCEDURE

Hyperinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours

Also known as: Intralipid

4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Type 2 diabetic patients age 18 - 60 yrs
• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Univerisity of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

soybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stephen N. Davis, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 27, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: April 1, 2014
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

US (1)