View Clinical Trial (Medical Research Study)
Effects of Hyperglycemia on Myocardial Perfusion in Humans With and Without Type 2 Diabetes: Modulation by Glucagon-Like-Peptide-1
| City: |
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Rochester |
| State: |
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Minnesota |
| Zip Code: |
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55905 |
| Conditions: |
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Coronary Artery Disease - Diabetes Mellitus Type 2 |
| Purpose: |
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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, 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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| Study Summary: |
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| 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.
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| NCT ID: |
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NCT01021865 |
| Primary Contact: |
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Principal Investigator
Ananda Basu, MBBS, M.D.
Mayo Clinic
Tamera M. Roberson, Res Coord
Phone: 507-255-8621
Email: roberson.tamera@mayo.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Rochester, Minnesota 55905
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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