Investigating Plasma Biomarker Molecules Associated With the Progression of Prediabetes to Overt Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT04851223|
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
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;
- Run large-scale proteomics and metabolomics analysis in pre-diabetic individuals to determine possible biomarker molecules.
- 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.
- 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).
|Condition or disease|
|Type2 Diabetes Mellitus Pre Diabetes|
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.
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||Biomarkers Identification for the Progression From Pre-diabetes to T2D|
|Actual Study Start Date :||March 22, 2021|
|Estimated Primary Completion Date :||October 14, 2021|
|Estimated Study Completion Date :||September 14, 2022|
- Body weight Measurements [ Time Frame: Changes from baseline to 6 and 9 months ]Weight in kilograms
- Body mass Index measurements [ Time Frame: Changes from baseline to 6 and 9 months ]kg/m^2
- Changes in insulin and glucose [ Time Frame: Changes from baseline to 6 and 9 months ]Effect of insulin and glucose levels expressed in mg/dl
- Changes in BCAA and its derivatives [ Time Frame: Changes from baseline to 6 and 9 months ]metabolites levels via mass spectrometry analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851223
|Contact: Richard W Mackenzieemail@example.com|
|University of Roehampton||Recruiting|
|London, United Kingdom, SW15 4JD|
|Contact: Richard Mackenzie, Dr. 07985749102 Richard.Mackenzie@roehampton.ac.uk|