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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053177
• Other study ID #: UoL001691
• Status: Recruiting
• Start date: January 25, 2023
• Est. completion date: February 3, 2025

Study information

• Verified date: September 2023
• Source: University of Liverpool
• Contact: David R Riley, MBBS
• Phone: 0151 529 5917
• Email: identify[@]liverpool.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 3, 2025
• Est. primary completion date: February 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fatty Liver
• Glucose Intolerance
• Heart Failure
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease
• Obstructive Sleep Apnea
• Pre Diabetes
• Prediabetic State
• Sleep Apnea, Obstructive
• Type 2 Diabetes

Locations

Country	Name	City	State
United Kingdom	Clinical Science Centre, Aintree University Hospital	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Peripheral neuropathy and cardiac autonomic dysfunction	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).	The data for this outcome measure is collected in a single study visit lasting approximately 2 and a half hours.
Secondary	Multi-morbidity screening	Exploration, through a questionnaire (mixture of open ended, closed and likert questions), of participants thoughts on multi-morbidity screening in high risk groups.	The data for this outcome is collected as part of the primary study visit lasting approximately 2 and a half hours.