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
  Purpose

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.


Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Autonomic Neuropathy and Myocardial Dysfunction in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

We will collect approximately 15 ml of whole blood for DNA sampling and storage.


Estimated Enrollment: 55
Study Start Date: May 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170832

Locations
United States, Michigan
University Of Michigan Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Cynthia D Plunkett, RNc, CCRC    734-936-8065    cplunket@umich.edu   
Contact: Amy Bonneau, BA    734-763-4156    abonneau@umich.edu   
Principal Investigator: Rodica Pop-Busui, MD, PhD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Rodica Pop-Busui, MD, Ph.D University of Michigan
  More Information

Additional Information:
No publications provided

Responsible Party: Rodica Pop-Busui, Associate Professor of Internal Medicine/MEND, University of Michigan
ClinicalTrials.gov Identifier: NCT01170832     History of Changes
Other Study ID Numbers: HUM 00036408
Study First Received: July 26, 2010
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014