To Evaluate if Wide Blood Sugar Fluctuations Lead to Injury of Heart Function and Heart Nerves
This proposal will test if, in patients with type 1 diabetes, wide blood glucose fluctuations lead to the injury to heart nerves , called cardiac autonomic neuropathy (CAN), and to impaired heart contractile (pumping) function and heart failure. It will also evaluate the natural history of heart failure and enhanced cardiac risk in patients with type 1 diabetes in the current standard of diabetes care.
Type 1 Diabetes Mellitus
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cardiac Autonomic Neuropathy and Myocardial Dysfunction in Type 1 Diabetes|
- Heart rate (HR) Variability Studies [ Time Frame: Three years ] [ Designated as safety issue: No ]Evaluation of heart rate variability and 24 hour blood pressure monitoring: electrocardiogram (ECG) and blood pressure will be recorded while resting in a lying down position and during certain controlled procedures that include deep breathing and other clinical maneuvers such as standing up and exhaling deeply.
- Positron Emission Tomography (PET) scan [ Time Frame: Test to be completed at baseline and end of study (3yrs) ] [ Designated as safety issue: No ]Subjects will have a heart positron emission tomography (PET) scan, using a radioisotope called [11C] hydroxyl-ephedrine (HED). This type of heart PET scan allows mapping the heart nerves. You will also have another scan with a radioisotope called [11C]-acetate which will help us measure the metabolism of your heart and how efficiently it contracts.
Biospecimen Retention: Samples With DNA
We will collect approximately 15 ml of whole blood for DNA sampling and storage.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170832
|United States, Michigan|
|University Of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48106|
|Contact: Cynthia D Plunkett, RNc, CCRC 734-936-8065 email@example.com|
|Contact: Amy Bonneau, BA 734-763-4156 firstname.lastname@example.org|
|Principal Investigator: Rodica Pop-Busui, MD, PhD|
|Principal Investigator:||Rodica Pop-Busui, MD, Ph.D||University of Michigan|