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