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

NCT06053177 | Active Not Recruiting

• 1 other identifier: UoL001691
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

screening; multi-morbidity

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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.

Secondary Outcomes (2)

• 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.

• Multi-morbidity screening

  The data for this outcome is collected as part of the primary study visit lasting approximately 2 and a half hours.

Study Arms (2)

Type 2 Diabetes

Participants with type 2 diabetes

Pre Diabetes

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who are able to give their written consent and have a diagnosis of type 2 diabetes or who's latest HbA1c is ≥42mmol/mol. Who receive their medical care in the Liverpool area (UK).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Liverpool: lead

Study Sites (1)

Clinical Science Centre, Aintree University Hospital

Liverpool, L9 7AL, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance; Sleep Apnea, Obstructive; Non-alcoholic Fatty Liver Disease; Heart Failure

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Uazman Alam, PhD

  The University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 25, 2023
• Study Start: January 25, 2023
• Primary Completion (Estimated): February 3, 2028
• Study Completion (Estimated): February 3, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)