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

Sponsor

University of Liverpool (Other)

Overall Status

Recruiting

CT.gov ID

NCT06053177

Collaborator

(none)

400

Enrollment

Location

24.3

Anticipated Duration (Months)

16.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Pre Diabetes Obstructive Sleep Apnea Non-Alcoholic Fatty Liver Disease Heart Failure

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Primary Care Screening to Rapidly Detect Multi-organ Complications for People With Prediabetes and Type 2 Diabetes

Actual Study Start Date :

Jan 25, 2023

Anticipated Primary Completion Date :

Feb 3, 2025

Anticipated Study Completion Date :

Feb 3, 2025

Arms and Interventions

Arm	Intervention/Treatment
Type 2 Diabetes Participants with type 2 diabetes
Pre Diabetes Participants who's most recent HbA1c is in the prediabetes range.

Outcome Measures

Primary Outcome Measures

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

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.