To Evaluate if Wide Blood Sugar Fluctuations Lead to Injury of Heart Function and Heart Nerves
This study is currently recruiting participants.
Verified May 2010 by University of Michigan
Sponsor:
University of Michigan
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01170832
First received: July 26, 2010
Last updated: August 4, 2011
Last verified: May 2010
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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: | October 2013 |
| Estimated Primary Completion Date: | August 2013 (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
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: | Dr. Rodica Pop-Busui, UMichigan |
| ClinicalTrials.gov Identifier: | NCT01170832 History of Changes |
| Other Study ID Numbers: | HUM 00036408 |
| Study First Received: | July 26, 2010 |
| Last Updated: | August 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on October 17, 2012
