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

2018年8月24日 更新者:Rodica Pop-Busui、University of Michigan

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.

研究概览

地位

完全的

研究类型

观察性的

注册 (预期的)

55

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Michigan
      • Ann Arbor、Michigan、美国、48106
        • University of Michigan

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

Type 1 diabetics who have been diagnosed between 5-10 years and do not have any complications that are associated with Diabetes

描述

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)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Heart rate (HR) Variability Studies
大体时间: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.
Three years

次要结果测量

结果测量
措施说明
大体时间
Positron Emission Tomography (PET) scan
大体时间: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.
Test to be completed at baseline and end of study (3yrs)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Rodica Pop-Busui, MD, Ph.D、University of Michigan

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年5月1日

初级完成 (实际的)

2016年8月1日

研究完成 (实际的)

2016年8月1日

研究注册日期

首次提交

2010年7月26日

首先提交符合 QC 标准的

2010年7月26日

首次发布 (估计)

2010年7月27日

研究记录更新

最后更新发布 (实际的)

2018年8月27日

上次提交的符合 QC 标准的更新

2018年8月24日

最后验证

2018年8月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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