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A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health and Disease

2016年10月24日 更新者:Olivier Thibault, PhD、University of Kentucky

A Pilot Feasibility Study of Fibroblast Calcium and Glucoregulation in Health

The purpose of this research is to better understand how calcium and glucose may play a role in people developing diabetes. By doing this study, the investigator hopes to learn whether abnormal calcium and glucose responses in skin biopsies from healthy patients and patients with Type 2 diabetes can identify and predict patients at greatest risk for later complications.

研究概览

地位

撤销

条件

详细说明

The overall goal of this proposal is to establish a pathophysiological index of a patient's status through imaging of calcium and glucose in skin fibroblasts. The investigator will obtain skin samples from patients in the Barnstable Brown Obesity and Diabetes Center at the University of Kentucky to test the hypothesis that calcium and glucose dysregulation are present in fibroblasts from patients with Type 2 diabetes, and are exaggerated in more difficult-to-treat patients or those with poor glucose control. The innovation of the project focuses on results that can potentially lead to earlier treatment for patients with diabetes and thereby reduce the risk for long-term complications.

Three levels of analyses will be conducted to assess the relationship between Ca2+ and glucose homeostasis in four patient groups (lean non-diabetics, obese non-diabetics, Type 2 Diabetics with good glucose control, and Type 2 Diabetics with poor control.

Participants will be required to attend only one study visit that will last approximately 2-3 hours. During the study subject will undergo the following: 1. Collection of two 4 ml tubes of blood for adiponectin analysis, 2. A skin biopsy, 3. Collection and review of medical history and current/past medication use 4. Collection of demographic information, 5. Height and weight measurement 6. Body mass index evaluation, 7. Vital signs assessment (blood pressure, pulse).

Follow-up for all enrolled patients will occur on a yearly basis through a phone interview.

The punch biopsy will be performed under local anesthesia.

研究类型

观察性的

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

    • Kentucky
      • Lexington、Kentucky、美国、40536
        • University of Kentucky Center for Clinical and Translational Science

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

40年 至 55年 (成人)

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

We will recruit both male and female participants. The age range for this study is 40-55 years old

描述

Inclusion Criteria:

  • Healthy
  • Type 2 Diabetes

Exclusion Criteria:

  • Under 40 years of age
  • Over 55 years of age
  • Pregnant or breastfeedig
  • Will not agree to a skin biopsy
  • Talking calcium channel blockers

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

队列和干预

团体/队列
Lean Non-Diabetic Group
Variables measured will also include serum analyses (HbA1c, adiponectin, cholesterol) and patient vital signs.
Pre-diabetics
These patients are anticipated to have elevated BMI, yet not be diabetics.
Diabetic Patients
These patients will have good glucose control.
Diabetic patients with poor glucocontrol
These patients are anticipated to have poor glucose control. They are usually taking insulin.

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
Are peak (nM) calcium responses to bradykinin enhanced along the continuum of disease in skin fibroblasts from the 4 patient groups?
大体时间:Three years
All participants groups will be compared statistically to the lean patient group.
Three years

次要结果测量

结果测量
措施说明
大体时间
Are glucose utilization rates (a.u./min) measured in skin fibroblasts from the 4 patient groups different with disease progression?
大体时间:Three years
A unitless index of health status based on serum analyses (cholesterol, adiponectin, HbA1c) for each patient will be correlated with a unitless index of glucose status based on fibroblast imaging data.
Three years

其他结果措施

结果测量
措施说明
大体时间
What component of peripheral metabolic dysregulation (HbA1c (%), adiponectin (ug/mL), cholesterol (mg/dL)) is associated with changes in calcium responses (nM) in skin fibroblasts?
大体时间:Three years
The investigator will also focus on two groups of patients, obese-non-diabetics and diabetics with poor control, during the analysis period and prospectively follow these patients for clinical outcomes.
Three years

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

  • 研究主任:Olivier Thibault, PhD、University of Kentucky

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

2013年10月1日

初级完成 (预期的)

2016年9月1日

研究完成 (预期的)

2016年9月1日

研究注册日期

首次提交

2013年7月31日

首先提交符合 QC 标准的

2013年8月6日

首次发布 (估计)

2013年8月7日

研究记录更新

最后更新发布 (估计)

2016年10月25日

上次提交的符合 QC 标准的更新

2016年10月24日

最后验证

2016年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 13-0571-F1V

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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