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临床试验/NCT03003793
NCT03003793已完成不适用

Insulin Sensitivity in Patients With Atopic Dermatitis

University Hospital, Gentofte, Copenhagen1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls

研究概览

简要总结

The incidence of atopic dermatitis and type 2 diabetes, respectively, has increased over many years. Novel research shows an association between the two conditions. While this relationship at least in theory can be explained by lifestyle factors, there is reason to believe that other pathophysiological mechanisms are involved. Hence, our hypothesis is that patients with atopic dermatitis are insulin resistant due to their chronic inflammatory state. Insulin resistance might play an unknown part in the increased frequency of type 2 diabetes among patients with atopic dermatitis. In the present project, the investigators aim to measure insulin sensitivity by means of the 'golden standard' hyperinsulinaemic euglycaemic clamp in patients suffering from atopic dermatitis compared to a healthy control group (matched case-control study). The project is a close collaboration between The Department of Dermatology and Allergy and Center for Diabetes Research at Gentofte Hospital.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate to severe atopic dermatitis for at least 5 years
  • BMI < 30 kg/m2
  • HbA1c < 42 mmol/mol

排除标准

  • Prediabetes
  • First-degree relatives with diabetes
  • Chronic inflammatory diseases other than atopic dermatitis and asthma
  • Pregnancy
  • Breast-feeding
  • Daily intake of medications that are known to influence the glucose metabolism are not allowed one month before the study (e.g. asthma medicines and hormonal contraception).

结局指标

主要结局

Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls

时间窗: Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp

The outcome is determined by measuring the glucose necessary to maintain euglycaemia during increased insulin levels generated by continuous insulin infusion (measured as the M-value: the rate of glucose infused is equal to the rate of whole-body glucose disposal or metabolizable glucose (M) and reflects the amount of exogenous glucose necessary to fully compensate for the hyperinsulinemia)

次要结局

未报告次要终点

研究者

发起方
University Hospital, Gentofte, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Filip Krag Knop

MD PhD

University Hospital, Gentofte, Copenhagen

研究点 (1)

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