Clinical Trial: To Evaluate if Wide Blood Sugar Fluctuations Lead to Injury of Heart Function and Heart Nerves

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Cardiac Autonomic Neuropathy and Myocardial Dysfunction in Type 1 Diabetes

Brief Summary: 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.

Detailed Summary:
Sponsor: University of Michigan

Current Primary Outcome: Heart rate (HR) Variability Studies [ Time Frame: Three years ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Positron Emission Tomography (PET) scan [ Time Frame: Test to be completed at baseline and end of study (3yrs) ]

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.


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: July 26, 2010
Date Started: May 2010
Date Completion: August 2017
Last Updated: October 24, 2016
Last Verified: October 2016