Effects of Hyperglycemia on Myocardial Perfusion in Humans With and Without Type 2 Diabetes
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease; Diabetes Mellitus Type 2
Intervention: Glucagon-Like-Peptide-1/Regadenoson/Perflutren Lipid Microsphere (Drug)
Phase: N/A
Status: Completed
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Ananda Basu, MBBS, M.D., Principal Investigator, Affiliation: Mayo Clinic
Sharon L Mulvagh, M.D., Principal Investigator, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: Effects of Hyperglycemia on Myocardial Perfusion in Humans With and Without Type 2 Diabetes: Modulation by Glucagon-Like-Peptide-1
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: To determine whether hyperglycemia alters myocardial perfusion in subjects with type 2 diabetes
Secondary outcome: To determine whether GLP-1 modulates myocardial perfusion in subjects with type 2 diabetes.
Eligibility
Minimum age: 40 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Starting date: February 2010
Last updated: July 3, 2015
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