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临床试验/NCT06053177
NCT06053177进行中(未招募)不适用

Primary Care Screening to Rapidly Detect Multi-organ Complications for People With Prediabetes and Type 2 Diabetes

University of Liverpool2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
400
试验地点
2
主要终点
The prevalence of undiagnosed fatty liver disease with evidence of fibrosis, obstructive sleep apnoea and heart failure in people with type 2 diabetes and prediabetes

研究概览

简要总结

People with type 2 diabetes are at risk of complications linked with high blood sugars and these are monitored for in healthcare appointments. However, people with type 2 diabetes commonly suffer with additional health conditions that can affect the liver, heart and their breathing while sleeping. These conditions are thought to be caused by a similar underlying process that causes type 2 diabetes, as a result they are very common in people type 2 diabetes. Despite this they are not part of the routine health check for these people. Worryingly, current research suggests that the risk for developing these health problems, and direct complications of type 2 diabetes, can start at blood sugar levels below the threshold of type 2 diabetes. In a group of people said to have prediabetes. These people do not currently undergo annual healthcare appointments to monitor for these health complications or other linked health conditions.

This study aims to pilot a new style of clinic to address these issues. The investigators will perform a multi-morbidity assessment, where they will look for several different health problems at the same time. The investigators will be looking at health problems linked with high blood sugars, this will include problems with the liver, heart, nerves, eyes, and participants breathing overnight. They have developed a clinic visit which uses questionnaires, simple examination techniques and modern devices to try and identify these health problems.

An important part of healthcare is the burden it places on people with health problems, with this in mind the investigators will be giving the people involved in their study a voice to try and direct future research and healthcare, the investigators will ask them to provide feedback on their experience in taking part in the study and what their thoughts are in undergoing a longer but more comprehensive health appointment.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes study group
  • Participants with a documented diagnosis of type 2 diabetes or HbA1c ≥48mmol/mol.
  • Age ≥18 years
  • Prediabetes study group
  • HbA1c 42 - 47 mmol/mol (inclusive) or enrolled in the diabetes prevention programme.
  • Age ≥18 years

排除标准

  • Type 1, 3 or Maturity onset diabetes of the young.
  • Participants who are pregnant at the time of screening
  • Unable to give informed consent

研究组 & 干预措施

Type 2 Diabetes

Participants with type 2 diabetes

Pre Diabetes

Participants who's most recent HbA1c is in the prediabetes range.

结局指标

主要结局

The prevalence of undiagnosed fatty liver disease with evidence of fibrosis, obstructive sleep apnoea and heart failure in people with type 2 diabetes and prediabetes

时间窗: The majority of the data for this outcome measure is collected in a single study visit lasting approximatley 2 and a half hours. All data for this outcome would be collected within 4 weeks of participant enrollment.

Participants will complete two screening questionnaires for sleep apnoea, those identified as high risk for the condition will be given a home sleep study device to confirm or reject the diagnosis. All participants will have a fibroscan to look for the presence of fatty liver disease. Participants will be screened for heart failure, with those identified as high risk undergoing an echocardiogram to confirm or reject the diagnosis.

次要结局

  • Peripheral neuropathy and cardiac autonomic dysfunction(The data for this outcome measure is collected in a single study visit lasting approximately 2 and a half hours.)
  • Multi-morbidity screening(The data for this outcome is collected as part of the primary study visit lasting approximately 2 and a half hours.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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