Effects of Hyperglycemia on Myocardial Perfusion in Humans With and Without Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-07-31

Brief Summary

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The overall goal of this proposal is to determine the effects of acute hyperglycemia and its modulation by Glucagon-like Peptide-1 (GLP-1) on myocardial perfusion in type 2 diabetes (DM). This study plan utilizes myocardial contrast echocardiography (MCE) to explore a) the effects of acute hyperglycemia on myocardial perfusion and coronary flow reserve in individuals with and without DM; and b) the effects of GLP-1 on myocardial perfusion and coronary flow reserve during euglycemia and hyperglycemia in DM. The investigators will recruit individuals with and without DM matched for age, gender and degree of obesity. The investigators will measure myocardial perfusion at rest and during vasodilator stress (to ascertain coronary flow reserve) while subjects are under controlled pancreatic clamp conditions during euglycemia (glucose \~100 mg/dl) and hyperglycemia (glucose \~250 mg/dl) in the presence and absence of concomitant GLP-1 infusion. The investigators believe that the translational significance of their studies is immense, impacting upon both acute and chronic cardiovascular disease manifestations. The effect of glycemic control on cardiovascular outcomes, morbidity and mortality remains an area of active investigation, fueled by the recent conflicting results of several large clinical trials (ACCORD, United Kingdom Prospective Diabetes Study (UKPDS), ADVANCE, VADT). If the investigators find that hyperglycemia is associated with altered myocardial perfusion, the mechanistic implications in the prevention and management of acute and chronic cardiovascular diseases in DM will be groundbreaking. Furthermore, if GLP-1 augments myocardial perfusion (as it does in the peripheral vasculature), the therapeutic benefits for prevention of cardiovascular events in this predisposed population are clear.

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Detailed Description

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Conditions

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Coronary Artery Disease Diabetes Mellitus Type 2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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With type 2 Diabetes

Glucagon-Like-Peptide-1/Regadenoson/Perflutren Lipid Microsphere

Intervention Type DRUG

GLP-1 at a rate of 1.2 pmol/kg/min

Regadenoson as a stress agent 0.4mg IV given during MCE

Definity:0.6 ml of Definity diluted with 30ml of 0.9% saline infused by SYRINGE Infusion Pump

Without type 2 diabetes

Glucagon-Like-Peptide-1/Regadenoson/Perflutren Lipid Microsphere

Intervention Type DRUG

GLP-1 at a rate of 1.2 pmol/kg/min

Regadenoson as a stress agent 0.4mg IV given during MCE

Definity:0.6 ml of Definity diluted with 30ml of 0.9% saline infused by SYRINGE Infusion Pump

Interventions

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Glucagon-Like-Peptide-1/Regadenoson/Perflutren Lipid Microsphere

GLP-1 at a rate of 1.2 pmol/kg/min

Regadenoson as a stress agent 0.4mg IV given during MCE

Definity:0.6 ml of Definity diluted with 30ml of 0.9% saline infused by SYRINGE Infusion Pump

Intervention Type DRUG

Other Intervention Names

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Lexiscan Definity

Eligibility Criteria

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Inclusion Criteria

* Males and females
* Age 40-60 years
* BMI\< or = 35 kg/m2
* Diabetic subjects with HbA1c concentrations of \< or = 8%.
* Diabetic subjects will be either on diet and lifestyle therapy alone, or monotherapy with metformin or sulphonylureas (except glyburide).
* All diabetic subjects should be on stable dose oral agent therapy for 3 months prior to enrollment.

Exclusion Criteria

* Subjects with cerebrovascular or peripheral vascular disease.
* Subjects with suspected or overt autonomic neuropathy.
* Diabetic subject on thiazolidinediones, insulin, GLP-1 based therapies (exenatide or sitagliptin), alpha-glucosidase inhibitors, glyburide or combination antidiabetic drug therapies.
* Diabetics with microalbuminuria.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes