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临床试验/NCT02413762
NCT02413762已完成不适用

The Role of Gut Hormones and Hepcidin in Type 2 Diabetes Mellitus

Imperial College London Diabetes Centre1 个研究点 分布在 1 个国家目标入组 1,512 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
已完成
入组人数
1,512
试验地点
1
主要终点
Microvascular complication of diabetes mellitus - prevalence and incidence

研究概览

简要总结

This study aims to investigate the potential of the gut hormones GLP-1, PP, PYY and the iron regulatory hormone hepcidin as biomarkers for progression to complications in diabetes mellitus.

详细描述

Iron overload and mechanisms inducing insulin resistance are reciprocally linked. Dietary iron absorption, and iron uptake in liver and adipose tissue, are regulated through the hormone hepcidin. Iron is implicated in microvascular and macrovascular disease pathways and therefore hepcidin may represent a biomarker for progression to complications in type 2 diabetes mellitus.

Serum pancreatic polypeptide levels correlate with visceral adiposity and may therefore contribute to the diagnosis of, and risk stratification in, the metabolic syndrome.

Hypothesis:

Measuring iron status, incretin hormones and serum pancreatic polypeptide will facilitate discrimination of patients at risk of vascular complications of T2DM and clinically significant non-alcoholic fatty liver disease.

Statistical analysis:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • 未提供

排除标准

  • lack of capacity for informed consent; vulnerable individuals

结局指标

主要结局

Microvascular complication of diabetes mellitus - prevalence and incidence

时间窗: 5 years

Prevalence at enrolment and subsequent incidence of background diabetic retinopathy, preproliferative or proliferative retinopathy, or diabetic maculopathy; microalbuminuria defined as two episodes \> 3 months apart of ACR \> 2.5 (male) or \> 3.5 (female) mg/umol. Assessed through patient recall and examination of electronic medical record.

Macrovascular complication of diabetes mellitus - prevalence and incidence

时间窗: 5 years

Prevalence at enrolment and subsequent incidence of composite endpoint of coronary artery disease (MI, ACS, percutaneous intervention), cerebrovascular disease (CVA, TIA), and peripheral arterial disease (ischaemic peripheral ulcer, revascularisation procedure, amputation). Assessed through patient recall and examination of electronic medical record.

次要结局

  • Progression to NAFLD or NASH(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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