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

Active, not recruiting

• Conditions: Pre Diabetes; Non-Alcoholic Fatty Liver Disease; Heart Failure; Type 2 Diabetes; Obstructive Sleep Apnea

• Registration Number: NCT06053177
• Lead Sponsor: University of Liverpool

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-01-25
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22
• Primary Completion: 2028-02-03
• Study Completion: 2028-02-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of undiagnosed fatty liver disease with evidence of fibrosis, obstructive sleep apnoea and heart failure in people with type 2 diabetes and prediabetes	The majority of the data for this outcome measure is collected in a single study visit lasting approximatley 2 and a half hours. All data for this outcome would be collected within 4 weeks of participant enrollment.	Participants will complete two screening questionnaires for sleep apnoea, those identified as high risk for the condition will be given a home sleep study device to confirm or reject the diagnosis. All participants will have a fibroscan to look for the presence of fatty liver disease. Participants will be screened for heart failure, with those identified as high risk undergoing an echocardiogram to confirm or reject the diagnosis.

Secondary Outcome Measures

Name	Time	Method
Peripheral neuropathy and cardiac autonomic dysfunction	The data for this outcome measure is collected in a single study visit lasting approximately 2 and a half hours.	The prevalence of peripheral neuropathy and cardiac autonomic dysfunction will be assessed using specifically designed, validated and non-invasive medical devices with results compared against outcomes of the clinical peripheral neuropathy assessments (including the MNSI, painDETECT and neuropathy symptom profile questionnaires).
Multi-morbidity screening	The data for this outcome is collected as part of the primary study visit lasting approximately 2 and a half hours.	Exploration, through a questionnaire (mixture of open ended, closed and likert questions), of participants thoughts on multi-morbidity screening in high risk groups.

Trial Locations

Locations (1)

Clinical Science Centre, Aintree University Hospital; 🇬🇧 Liverpool, United Kingdom