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临床试验/NCT02348099
NCT02348099终止不适用

Ultrasound Guided Detection and Characterization of Subclinical Lipohypertrophy in Type 1 and Type 2 Diabetes Mellitus

University of British Columbia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
100
试验地点
1
主要终点
Number of Participants With Presence of Subclinical Lipohypertrophy

研究概览

简要总结

This is a pilot study to enroll 100 people to assess the incidence of lipohypertrophy as detected with ultrasound and its impact on glycemic variability.

详细描述

Lipohypertrophy is a well documented phenomenon in patients with diabetes in which hypertrophy and differentiation of adipocytes occurs in the dermal reticular layer at the sites of subcutaneous insulin injection. Currently, lipohypertrophy is assessed by palpating insulin injection sites. The detection on early, non palpable (subclinical) lipohypertrophy remains difficult in the clinical setting. Recent studies have identified distinct ultrasonographic features of hyperechogenicity in areas of adipose tissue consistent with clinical evidence of lipohypertrophy at insulin injection sites, and have detected changes int he thickness of subcutaneous tissue where not clinically evident in population of patients with type 1 diabetes. Lipohypertrophy can adversely affect glycemic control. Injecting into lipohypertrophic areas leads to poor absorption and the need for increasing doses of insulin.

In this study study participants will undergo an assessment for lipohypertrophy during a scheduled visit at the VGH Diabetes Centre. A Diabetes Nurse will assess lipohypertrophy by palpation according to the FIT Protocol. A second diabetes nurse who was not present at the palpation will assess insulin injection sites for lipohypertrophy by ultrasound using a linear probe.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • 19 years of age or older
  • Type 1 or Type 2 diabetes
  • Using insulin to manage diabetes for at least 2 years

排除标准

  • Using insulin pumps, insulin secretagogues, Glucagon-Like Peptide-1 (GLP-1) agonists to manage diabetes
  • Use of immunosuppressant agents
  • Women who are pregnant

结局指标

主要结局

Number of Participants With Presence of Subclinical Lipohypertrophy

时间窗: Assessed one time only at the time of clinic visit

Lipohypertrophy seen on ultrasound but not felt by palpation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Graydon Meneilly

Professor, UBC Department of Medicine

University of British Columbia

研究点 (1)

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