Effects of Hyperglycemia on Myocardial Perfusion in Humans With and Without Type 2 Diabetes (GLP-1)
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| ClinicalTrials.gov Identifier: NCT01021865 |
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Recruitment Status :
Completed
First Posted : November 30, 2009
Last Update Posted : July 7, 2015
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| Condition or disease | Intervention/treatment |
|---|---|
| Coronary Artery Disease Diabetes Mellitus Type 2 | Drug: Glucagon-Like-Peptide-1/Regadenoson/Perflutren Lipid Microsphere |
| Study Type : | Observational |
| Actual Enrollment : | 33 participants |
| 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 |
| Study Start Date : | February 2010 |
| Actual Primary Completion Date : | July 2014 |
| Actual Study Completion Date : | July 2014 |
| Group/Cohort | Intervention/treatment |
|---|---|
| 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:
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| 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:
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- To determine whether hyperglycemia alters myocardial perfusion in subjects with type 2 diabetes [ Time Frame: Nov 2009-2011 ]
- To determine whether GLP-1 modulates myocardial perfusion in subjects with type 2 diabetes. [ Time Frame: Nov 2009-2011 ]
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| Ages Eligible for Study: | 40 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021865
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | Ananda Basu, MBBS, M.D. | Mayo Clinic | |
| Principal Investigator: | Sharon L Mulvagh, M.D. | Mayo Clinic |
Publications of Results:
| Responsible Party: | Sharon Mulvagh, PI, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01021865 History of Changes |
| Other Study ID Numbers: |
08-008750 |
| First Posted: | November 30, 2009 Key Record Dates |
| Last Update Posted: | July 7, 2015 |
| Last Verified: | July 2015 |
Keywords provided by Sharon Mulvagh, Mayo Clinic:
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GLP-1 Myocardial contrast echocardiography Myocardial perfusion |
Additional relevant MeSH terms:
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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 |