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Investigating Plasma Biomarker Molecules Associated With the Progression of Prediabetes to Overt Type 2 Diabetes

2022年5月17日 更新者:Richard Mackenzie、University of Roehampton

Biomarkers Identification for the Progression From Pre-diabetes to T2D

There are an estimate 7 million people in the United Kingdom living with pre-diabetes. The increasing number of new cases of pre-diabetes presents a global health concern due to funding implications.

The progression from pre-diabetes to overt type 2 diabetes is often characterised by a reduction in insulin secretion (or β-cell dysfunction). Whilst inflammation may contribute to β-cell dysfunction, a complete picture is still lacking. The proposed research will help develop a more complete understanding of the molecules that may trigger β-cell failure, a process that often connects pre-diabetes to overt diabetes.

The aims of this project are;

  1. Run large-scale proteomics and metabolomics analysis in pre-diabetic individuals to determine possible biomarker molecules.
  2. Use measures and / or classifications of insulin resistance and diabetes (i.e. β-cell function and Disposition Index) to establish whether particular metabolic and / or proteomic signatures (aim 1) are associated with the development of pre-diabetes.
  3. To determine if the possible metabolite or protein profile changes are associated with the progression or regression of pre-diabetes from baseline (0 month) to the end of the National Diabetes Prevention Programme (NDPP) (9 month).

研究概览

地位

招聘中

详细说明

Type 2 diabetes mellitus (T2DM) is a complex metabolic disease characterised by elevated blood sugar. This represents a worldwide concern due to the secondary complications associated with type 2 diabetes, which are considered an important cause of early death; particularly, given the predicted increase. The cost associated with the treatment and the complications associated with diabetes reaches £10 billion every year and it is expected to increase. From approximately 425 million (2017) it is projected that 629 million adults will be living with diabetes by 2045. Therefore, this matter requires effective interventions aimed at improving blood sugar control, reducing the burden on the economy while improving the quality of life among T2DMs.

Insulin, a hormone that is allowing the body to use or store sugar derived from food, is manufactured by the β-cells in the pancreas. The progression from pre-diabetes to overt type 2 diabetes is typically diagnosed at the point of β-cell failure. Several factors are known to contribute to β-cell dysfunction such as: obesity (especially abdominal obesity), high blood pressure and elevated fats in the blood. Around 80% of the people who have been diagnosed with T2DM are either obese or overweight and they have been observed to have increased levels of fatty acids in the blood following a meal, which can induce insulin resistance. High levels of fatty acids have also been associated with an increased production of pro-inflammatory cytokines, which are small proteins that have an effect on organs or other cells, contributing to chronic inflammation. High levels of chronic inflammation increase the chances of developing metabolic disorders such as T2DM. However, a complete picture of this process is still lacking.

The proposed study will help develop a more complete understanding of the molecules that may trigger β-cell failure.

The identification of these molecules that are implicated in β-cell failure, can lead to the development of targeted interventions for those at risk of developing type 2 diabetes and potentially preventing habitual hyperglycaemia and type 2 diabetes.

研究类型

观察性的

注册 (预期的)

130

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Pre-diabetic individuals

描述

Inclusion Criteria:

Pre-diabetic individuals between 18 and 65 years of age

Pre-diabetes criteria:

  • Glycated hemoglobin (HbA1c) values between 42 - 47 mmol/mol
  • Fasting plasma glucose levels between 6.1 - 6.9 mmol/L
  • Blood pressure <140 mmHg systolic/ <90 mmHg diastolic

Exclusion Criteria:

  • Individuals suffering from any complications (i.e. nerve or kidney disorders, damage of the retina, vascular diseases, strokes, persistent high blood pressure, cardiovascular disease,haemophilia), those with anaemia, blood borne diseases, those who are pregnant or in the postpartum period (within 3 months after delivery), have high blood pressure >140 mmHg systolic/ >90 mmHg diastolic, current smokers, individuals requiring strong anticoagulant medication, such as warfarin (the anticoagulant effect of non-steroidal anti-inflammatory drugs is too small to pose a hazard), insulin or other medications affecting the typical levels of blood glucose are unfortunately unable to take part in this study. Individuals must not be involved in any other study which involves the sampling of blood and must not have donated blood in the last 12 weeks (for males) or 16 weeks (for females). A health questionnaire will be carried out to confirm your eligibility for the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Pre Diabetics

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Body weight Measurements
大体时间:Changes from baseline to 6 and 9 months
Weight in kilograms
Changes from baseline to 6 and 9 months
Body mass Index measurements
大体时间:Changes from baseline to 6 and 9 months
kg/m^2
Changes from baseline to 6 and 9 months
Changes in insulin and glucose
大体时间:Changes from baseline to 6 and 9 months
Effect of insulin and glucose levels expressed in mg/dl
Changes from baseline to 6 and 9 months
Changes in BCAA and its derivatives
大体时间:Changes from baseline to 6 and 9 months
metabolites levels via mass spectrometry analysis
Changes from baseline to 6 and 9 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月22日

初级完成 (预期的)

2023年6月22日

研究完成 (预期的)

2023年9月22日

研究注册日期

首次提交

2021年1月14日

首先提交符合 QC 标准的

2021年4月19日

首次发布 (实际的)

2021年4月20日

研究记录更新

最后更新发布 (实际的)

2022年5月18日

上次提交的符合 QC 标准的更新

2022年5月17日

最后验证

2022年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • LSC 20/ 311
  • 245301 (其他标识符:IRAS ID)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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