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

NCT04851223 | Unknown

• 2 other identifiers: LSC 20/ 311245301
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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. 1.Run large-scale proteomics and metabolomics analysis in pre-diabetic individuals to determine possible biomarker molecules.
2. 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. 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).

Conditions

Type2 Diabetes Mellitus; Pre Diabetes

Outcome Measures

Primary Outcomes (4)

• Body weight Measurements

  Weight in kilograms

  Changes from baseline to 6 and 9 months

• Body mass Index measurements

  kg/m\^2

  Changes from baseline to 6 and 9 months

• Changes in insulin and glucose

  Effect of insulin and glucose levels expressed in mg/dl

  Changes from baseline to 6 and 9 months

• Changes in BCAA and its derivatives

  metabolites levels via mass spectrometry analysis

  Changes from baseline to 6 and 9 months

Study Arms (1)

Pre Diabetics

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pre-diabetic individuals

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roehampton: lead

Study Sites (1)

University of Roehampton

London, SW15 4JD, United Kingdom

RECRUITING

Related Publications (2)

• Mokdad AH, Ford ES, Bowman BA, Dietz WH, Vinicor F, Bales VS, Marks JS. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003 Jan 1;289(1):76-9. doi: 10.1001/jama.289.1.76.

  PMID: 12503980 BACKGROUND

• Reaven GM, Hollenbeck C, Jeng CY, Wu MS, Chen YD. Measurement of plasma glucose, free fatty acid, lactate, and insulin for 24 h in patients with NIDDM. Diabetes. 1988 Aug;37(8):1020-4. doi: 10.2337/diab.37.8.1020.

  PMID: 3292322 BACKGROUND

Biospecimen

plasma

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Richard W Mackenzie

CONTACT

+447985749102; richard.mackenzie@roehampton.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: April 20, 2021
• Study Start: March 22, 2021
• Primary Completion: June 22, 2023
• Study Completion: September 22, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

GB (1)