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临床试验/NCT03229850
NCT03229850撤回不适用

Dynamics of Insulin Absorption in Subclinical Lipohypertrophy Using the Euglycemic Clamp Technique

Graydon Meneilly1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
10
试验地点
1
主要终点
Insulin Levels

研究概览

简要总结

This study will use the euglycemic clamp technique to evaluate insulin absorption when insulin is administered subcutaneously in an area of subclinical lipohypertrophy vs an area of normal tissue.

详细描述

The use of insulin to manage diabetes can cause changes to the skin at sites where insulin is administered. These changes may be felt as lumps under the skin. Insulin injected into these areas may not work as well leading to needing increasing doses of insulin to control blood glucose levels. Hypoglycemia can occur when insulin is injected into normal areas. Previous studies have found that these lipohypertrophic areas can be seen on ultrasound before they can be felt. The Investigators will be using the euglycemic clamp techique to evaluate insulin absorption to see whether tissue with lumps that cannot be felt but are seen on ultrasound affect how insulin is absorbed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

During one euglycemic clamp study, insulin lispro will be injected subcutaneously into an area of subclinical lipohypertrophy of the abdomen identified by ultrasound, during the other insulin lispro will be injected to an area with no subclinical lipohypertrophy.

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

  • Participated in Glycemic Variability study
  • Type 2 Diabetes for at least 2 years
  • Currently using insulin to manage diabetes
  • Have used insulin to manage diabetes for at least 2 years
  • Age 19 or older
  • BMI < 30 kg/m2
  • Confirmed areas of subclinical lipohypertrophic adipose tissue lesions via ultrasound

排除标准

  • Taking other injectable medications (eg liraglutide/Victoza
  • Taking systemic steroids (ie prednisone)
  • Severe renal insufficiency (eGFR < 30 ml/min/1.73 m2
  • Hypoglycemic unawareness
  • Current pregnancy
  • Not fluent in speaking and writing English (unless accompanied by a translator)

研究组 & 干预措施

Subclinical Lipohypertrophy

Other

Insulin lispro will be injected in the abdomen into an area of subclinical lipohypertrophy.

干预措施: Insulin lispro (Drug)

No Subclinical Lipohypertrophy

Other

Insulin lispro will be injected in the abdomen into an area where there is no subclinical lipohypertrophy.

干预措施: Insulin lispro (Drug)

结局指标

主要结局

Insulin Levels

时间窗: 2 months

The euglycemic clamp technique will be used. Insulin levels will be analyzed by Eliza assay

次要结局

未报告次要终点

研究者

发起方
Graydon Meneilly
申办方类型
Other
责任方
Sponsor 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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