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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04851223
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Information provided by (Responsible Party):
Richard Mackenzie, University of Roehampton

Brief Summary:

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).

Condition or disease
Type2 Diabetes Mellitus Pre Diabetes

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Pre Diabetics

Primary Outcome Measures :
  1. Body weight Measurements [ Time Frame: Changes from baseline to 6 and 9 months ]
    Weight in kilograms

  2. Body mass Index measurements [ Time Frame: Changes from baseline to 6 and 9 months ]

  3. 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

  4. Changes in BCAA and its derivatives [ Time Frame: Changes from baseline to 6 and 9 months ]
    metabolites levels via mass spectrometry analysis

Biospecimen Description:

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pre-diabetic individuals

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04851223

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Contact: Richard W Mackenzie +447985749102

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United Kingdom
University of Roehampton Recruiting
London, United Kingdom, SW15 4JD
Contact: Richard Mackenzie, Dr.    07985749102   
Sponsors and Collaborators
University of Roehampton
Additional Information:
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Responsible Party: Richard Mackenzie, Dr., University of Roehampton Identifier: NCT04851223    
Other Study ID Numbers: LSC 20/ 311
245301 ( Other Identifier: IRAS ID )
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases