Longitudinal Assessment of Multiple Organs in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Perspectum
- 入组人数
- 135
- 试验地点
- 4
- 主要终点
- Magnetic Resonance Imaging metrics for liver fibro-inflammation in patients with type 2 diabetes
研究概览
简要总结
MODIFY study is a multi-centre prospective, longitudinal, observational cohort study which aims to recruit 150 adult patients with type 2 diabetes recruited from community, primary care or secondary care settings. The total length of the study is 75 months. The aim of the study is to develop an MRI-based method to identify whom amongst people with Type 2 diabetes are at risk of further complications in their kidney, liver and cardiovascular system.
详细描述
There has been a surge in incidence of the metabolic syndrome; a cluster of conditions which increase the risk of, type 2 diabetes (T2D) (90% of diabetes cases), non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), cardiovascular disease (including ischaemic heart disease and heart failure), ischaemic or haemorrhagic stroke
This project concentrates on T2D, a disease whose multiple patho-physiological defects include; increased renal glucose re-absorption, decreased peripheral glucose utilisation, increased hepatic glucose production due to insulin resistance, increased glucagon secretion, reduced insulin secretion (pancreas), and incretin secretion (gastrointestinal tract)
Estimated UK prevalence of T2D is 5.26%. This represents 3.3 million people (comparatively in the US, 9.1% or 26.44 million people), which equates to £8.8bn in associated healthcare costs in UK.
Type 2 diabetes is associated with a heterogeneity in its aetiology - this is observed in its clinical presentation and subsequent rate of progression. Further factors associated with T2D include micro-and macrovascular complications and an observed decline in multiple organs (end-organ damage). End-organ damage contributes to the clinical picture of individuals with T2D and is demonstrated when observing the high prevalence of co-morbidities in this patient cohort. For example, the presence of NAFLD is seen in 60% of T2D patients, along with a 34.2-50.7% presence of chronic kidney disease (CKD) and a 32.2% presence of cardiovascular disease (CVD).
Currently, T2D and its complications are monitored using circulating plasma and serum biomarkers. However, these lack sufficient sensitivity or specificity. An example of this is highlighted in one researcher's preliminary data that suggests that 85% of obese people with T2D had NAFLD, detected by MRI. However, a vast proportion of this patient cohort have recorded normal biochemical biomarkers, such as Alanine Transaminase (ALT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 18 years of age and diagnosed with type 2 diabetes.
- •Participant currently taking glucose lowering therapy.
- •Participant willing and able to give informed consent for participation in the study.
排除标准
- •The participant may not enter the study if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
- •Patients with known autoimmune hepatitis, viral hepatitis, Wilson's disease, haemoglobinopathies or significant structural renal tract abnormality.
- •Patients with known excessive alcohol intake.
- •Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study.
结局指标
主要结局
Magnetic Resonance Imaging metrics for liver fibro-inflammation in patients with type 2 diabetes
时间窗: 1 year
In order to determine the degree of liver fibro-inflammation in this cohort of patients with type 2 diabetes multi-parametric abdominal MRI will be performed. the measurements following the Multi parametric MRI in the type 2 diabetic patients will be compared with the same type of measurements in healthy individuals
次要结局
- Correlation between Magnetic Resonance Imaging metrics for liver Fat infiltration and volume in patients with type 2 diabetes vs healthy people.(1 year)
- Correlation between Magnetic Resonance Imaging metrics for Pancreas, spleen, kidney and aorta indicating co-morbidities in patients with type 2 diabetes vs healthy people.(1 year)
- Detecting change in liver, spleen, pancreas and kidney using Magnetic Resonance Imaging metrics from baseline to 9 months(9 months)
- Detecting change in liver, spleen, pancreas and kidney using conventional biochemical biomarkers from baseline to 9 months(9 months)
- Impact of Multi parametric abdominal MRI on management of patients with type 2 diabetes(1 year)
- longer term evaluation of clinical outcomes(5 years)