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Effects of Hyperglycemia on Myocardial Perfusion in Humans With and Without Type 2 Diabetes (GLP-1)
This study has been completed.
Sponsor:
Mayo Clinic
Collaborators:
University of Nebraska
Astellas Pharma US, Inc.
Lantheus Medical Imaging
Information provided by (Responsible Party):
Sharon Mulvagh, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01021865
First received: October 30, 2009
Last updated: July 3, 2015
Last verified: July 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
| Coronary Artery Disease Diabetes Mellitus Type 2 | Drug: Glucagon-Like-Peptide-1/Regadenoson/Perflutren Lipid Microsphere |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Effects of Hyperglycemia on Myocardial Perfusion in Humans With and Without Type 2 Diabetes: Modulation by Glucagon-Like-Peptide-1 |
Resource links provided by NLM:
Further study details as provided by Sharon Mulvagh, Mayo Clinic:
Primary Outcome Measures:
- To determine whether hyperglycemia alters myocardial perfusion in subjects with type 2 diabetes [ Time Frame: Nov 2009-2011 ]
Secondary Outcome Measures:
- To determine whether GLP-1 modulates myocardial perfusion in subjects with type 2 diabetes. [ Time Frame: Nov 2009-2011 ]
| Enrollment: | 33 |
| Study Start Date: | February 2010 |
| Study Completion Date: | July 2014 |
| Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| With type 2 Diabetes |
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 Other Names:
|
| Without type 2 diabetes |
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 Other Names:
|
Eligibility| Ages Eligible for Study: | 40 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
25 subjects with type 2 diabetes and 25non-diabetic subjects matched for age, gender and degree of obesity will be studied.
The diabetic subjects will be between 40 and 60 years of age and will have a body mass index of < or =35 kg/m2. Diabetic subjects treated according to ADA guidelines will be eligible for study including a blood pressure < 140/90, LDL cholesterol < 130 mg/dl, HDL cholesterol >40 mg/dl and triglycerides <200 mg/dl.
All nondiabetic subjects will not have a history of diabetes in their first degree family members. None of the subjects will have any overt evidence of cardiac, renal, pulmonary or hepatic disorder nor will they be engaging in regular vigorous physical activities. All subjects will undergo a resting ECG and a treadmill ECG test to ensure that they do not have active or occult coronary artery disease unless such testing had been completed within six months of enrollment and reported as normal.
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01021865
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021865
Locations
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
Sponsors and Collaborators
Mayo Clinic
University of Nebraska
Astellas Pharma US, Inc.
Lantheus Medical Imaging
Investigators
| Principal Investigator: | Ananda Basu, MBBS, M.D. | Mayo Clinic |
| Principal Investigator: | Sharon L Mulvagh, M.D. | Mayo Clinic |
More Information
Publications:
| Responsible Party: | Sharon Mulvagh, PI, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01021865 History of Changes |
| Other Study ID Numbers: |
08-008750 |
| Study First Received: | October 30, 2009 |
| Last Updated: | July 3, 2015 |
Keywords provided by Sharon Mulvagh, Mayo Clinic:
|
GLP-1 Myocardial contrast echocardiography Myocardial perfusion |
Additional relevant MeSH terms:
|
Diabetes Mellitus Coronary Artery Disease Myocardial Ischemia Coronary Disease Hyperglycemia Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Glucagon Glucagon-Like Peptide 1 Regadenoson Gastrointestinal Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Incretins Adenosine A2 Receptor Agonists Purinergic P1 Receptor Agonists Purinergic Agonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 21, 2017