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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01170832
Recruitment Status : Active, not recruiting
First Posted : July 27, 2010
Last Update Posted : August 1, 2017
Information provided by (Responsible Party):
Rodica Pop-Busui, University of Michigan

July 26, 2010
July 27, 2010
August 1, 2017
May 2010
August 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01170832 on Archive Site
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.
Same as current
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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.
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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
We will collect approximately 15 ml of whole blood for DNA sampling and storage.
Probability Sample
Type 1 diabetics who have been diagnosed between 5-10 years and do not have any complications that are associated with Diabetes
Type 1 Diabetes Mellitus
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
August 2018
August 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
HUM 00036408
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Rodica Pop-Busui, University of Michigan
University of Michigan
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Principal Investigator: Rodica Pop-Busui, MD, Ph.D University of Michigan
University of Michigan
July 2017