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

Cardiac Autonomic Neuropathy and Myocardial Dysfunction in Type 1 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus

• Study Type: Observational
• Enrollment (Anticipated): 55

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Type 1 diabetics who have been diagnosed between 5-10 years and do not have any complications that are associated with Diabetes

Description

Inclusion/Exclusion Criteria:

• Male or female between the ages 18-65, with type 1 diabetes of 5-10 years duration who are free of complications and age-and-sex-matched healthy control volunteers.
• Hemoglobin A1c greater than 7 %. (For Type 1 diabetics)
• If you are a woman of childbearing potential you must agree to use an acceptable birth control method throughout the duration of the study. The methods of birth control that you can use are: Oral contraceptives (birth control pill), IUD or a barrier method (e.g. diaphragm or condom with spermicide).
• You should have no history of any cardiovascular disease including any form of coronary artery disease, congestive heart failure, known arrhythmias (irregular heart beats), valvular disease or high blood pressure.
• If you have any pacemaker or ICD, if you have any metallic foreign body such as surgical implants or clips or foreign bodies in the eye or orbits, wearing medication patches containing foil, or any other metal in the body or if you are claustrophobic you cannot participate in this study.
• You should be free of any diabetic complications (e.g. nephropathy or kidney damage, retinopathy or eye damage), have no history of previous kidney, pancreas or cardiac transplantation, any other severe chronic illness that has neuropathy (numbness, burning or tingling) and/or neurologic disease as a recognized complication (e.g. Parkinson's disease, epilepsy), or any other serious medical conditions that may shorten life span (e.g. disabling stroke, Chronic Obstructive Pulmonary Disease).
• You should be free of any malignancy other than basal cell skin cancer.
• No history of alcohol abuse.
• You should not use any agents or drugs that interfere with the imaging techniques described below.
• You must be able to cooperate with the test protocols that are described below and be willing to sign this consent form.

Inclusion for Control group:

• BMI <30
• If female, must not be pregnant or nursing
• Normal blood pressure
• Normal labs-(glucose and lipids)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate (HR) Variability Studies	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.	Three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positron Emission Tomography (PET) scan	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.	Test to be completed at baseline and end of study (3yrs)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Rodica Pop-Busui, MD, Ph.D, University of Michigan

Publications and helpful links

Helpful Links

• University of Michigan Research Trials Web site

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (Estimate): July 27, 2010

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 24, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: HUM 00036408