Status:

UNKNOWN

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

Lead Sponsor:

University of Roehampton

Conditions:

Type2 Diabetes Mellitus

Pre Diabetes

Eligibility:

All Genders

18-65 years

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. ...

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 diab...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 22 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 22 2023

Estimated Enrollment :

130 Patients enrolled

Trial Details

Trial ID

NCT04851223

Start Date

March 22 2021

End Date

September 22 2023

Last Update

May 18 2022

Active Locations (1)

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1

University of Roehampton

London, United Kingdom, SW15 4JD