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

NCT01021865 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2015-07-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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

Sponsors & Collaborators

  • University of Nebraska

    collaborator OTHER

  • Astellas Pharma US, Inc.

    collaborator INDUSTRY

  • Lantheus Medical Imaging

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Ananda Basu, MBBS, M.D. · Mayo Clinic

  • Sharon L Mulvagh, M.D. · Mayo Clinic

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01021865 on ClinicalTrials.gov