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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Rodica Pop-Busui, University of Michigan
ClinicalTrials.gov Identifier:
NCT01170832
First received: July 26, 2010
Last updated: December 13, 2013
Last verified: December 2013

July 26, 2010
December 13, 2013
May 2010
January 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01170832 on ClinicalTrials.gov Archive Site
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.
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
55
August 2015
January 2014   (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)
Both
18 Years to 65 Years
Yes
United States
 
NCT01170832
HUM 00036408
Yes
Rodica Pop-Busui, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Rodica Pop-Busui, MD, Ph.D University of Michigan
University of Michigan
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP