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临床试验/NCT01729130
NCT01729130已完成不适用

A Pilot Study to Identify the Differences in Adipose Tissue Function After Restoring Normal Glycemic Control Following Pancreas Transplantation

The University of Texas Medical Branch, Galveston1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Change in body fat distribution

研究概览

简要总结

Clinical measures of adipose tissue mass (BMI, waist circumference, waist-to-hip ratio) do not adequately explain the inter-individual and ethnic heterogeneity in diabetes. . There is a need to identify novel/universal markers of risk for diabetes (DM) and cardiovascular disease (CVD). These biomarkers also can become additional outcome measures for an intervention such as pancreatic/kidney transplant. If biological markers show an improvement with an intervention before anthropometric changes occur, intermediate outcomes can be an encouraging finding for practitioners. This study will focus on the central question of "adipose tissue dysfunction" as mediator of metabolic complications of positive energy balance, independent of body fat content and distribution. This study will address the question of effect of hyperglycemia on adipose tissue function independent of body fat mass. This project will take advantage of unique expertise of our investigators to perform detailed metabolic studies in patients with diabetes who undergo pancreatic/kidney transplant. The results of the proposed study will provide support to the novel approach of identifying adipose tissue dysfunction, rather than obesity and fat distribution, as predictor of diabetes and CVD across all ethnic groups, age and gender. We will obtain necessary preliminary data for future grant submissions to support our central hypothesis and develop stronger interactions within and outside The University of Texas Medical Branch (UTMB) with clinical investigators in the area of DM and its complications.

详细描述

detailed description is his protocol

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women of any ethnicity, and age between 18 and 65 years.
  • Patients with diabetes and renal failure who have been scheduled kidney-pancreas or isolated kidney transplantation.
  • Ability to speak read and understand English or Spanish

排除标准

  • Any evidence of acute or severe cardiopulmonary, thyroid, neurological disorders, as assessed by history and physical examination and laboratory testing.
  • Any personal history of substance abuse (reported only).
  • Alcohol intake above 7 grams/day.
  • Pregnancy or lactation.
  • Inability to give consent for this study.

结局指标

主要结局

Change in body fat distribution

时间窗: 1 year post transplantation

skinfold thickness changes from baseline to within 1 year post transplantation using tape measure, scale and calipers

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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