Multi-morbidity Screening in People With Type 2 Diabetes and Pre Diabetes

NCT ID: NCT06053177

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-25

Study Completion Date

2028-02-03

Brief Summary

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People with type 2 diabetes are at risk of complications linked with high blood sugars and these are monitored for in healthcare appointments. However, people with type 2 diabetes commonly suffer with additional health conditions that can affect the liver, heart and their breathing while sleeping. These conditions are thought to be caused by a similar underlying process that causes type 2 diabetes, as a result they are very common in people type 2 diabetes. Despite this they are not part of the routine health check for these people. Worryingly, current research suggests that the risk for developing these health problems, and direct complications of type 2 diabetes, can start at blood sugar levels below the threshold of type 2 diabetes. In a group of people said to have prediabetes. These people do not currently undergo annual healthcare appointments to monitor for these health complications or other linked health conditions.

This study aims to pilot a new style of clinic to address these issues. The investigators will perform a multi-morbidity assessment, where they will look for several different health problems at the same time. The investigators will be looking at health problems linked with high blood sugars, this will include problems with the liver, heart, nerves, eyes, and participants breathing overnight. They have developed a clinic visit which uses questionnaires, simple examination techniques and modern devices to try and identify these health problems.

An important part of healthcare is the burden it places on people with health problems, with this in mind the investigators will be giving the people involved in their study a voice to try and direct future research and healthcare, the investigators will ask them to provide feedback on their experience in taking part in the study and what their thoughts are in undergoing a longer but more comprehensive health appointment.

Detailed Description

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Conditions

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Type 2 Diabetes Pre Diabetes Obstructive Sleep Apnea Non-Alcoholic Fatty Liver Disease Heart Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Type 2 Diabetes

Participants with type 2 diabetes

No interventions assigned to this group

Pre Diabetes

Participants who's most recent HbA1c is in the prediabetes range.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Type 2 diabetes study group

* Participants with a documented diagnosis of type 2 diabetes or HbA1c ≥48mmol/mol.
* Age ≥18 years

Prediabetes study group

* HbA1c 42 - 47 mmol/mol (inclusive) or enrolled in the diabetes prevention programme.
* Age ≥18 years

Exclusion Criteria

* Type 1, 3 or Maturity onset diabetes of the young.
* Participants who are pregnant at the time of screening
* Unable to give informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liverpool

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uazman Alam, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Liverpool

Locations

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Clinical Science Centre, Aintree University Hospital

Liverpool, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UoL001691

Identifier Type: -

Identifier Source: org_study_id

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