Clinical trial NCT01170832: To Evaluate if Wide Blood Sugar Fluctuations Lead to Injury of Heart Function and Heart Nerves
Official title: Cardiac Autonomic Neuropathy and Myocardial Dysfunction in Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Heart rate (HR) Variability Studies
timeFrame: Three years
Secondary outcomes:
measure: Positron Emission Tomography (PET) scan
timeFrame: Test to be completed at baseline and end of study (3yrs)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University Of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Rodica Pop-Busui, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: