Clinical trial NCT06053177: Multi-morbidity Screening in People With Type 2 Diabetes and Pre Diabetes
Official title: Primary Care Screening to Rapidly Detect Multi-organ Complications for People With Prediabetes and Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Type 2 Diabetes
Pre Diabetes
Obstructive Sleep Apnea
Non-Alcoholic Fatty Liver Disease
Heart Failure
Keywords: screening
multi-morbidity
Lead sponsor: University of Liverpool
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 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:
measure: Peripheral neuropathy and cardiac autonomic dysfunction
timeFrame: The data for this outcome measure is collected in a single study visit lasting approximately 2 and a half hours.
measure: Multi-morbidity screening
timeFrame: The data for this outcome is collected as part of the primary study visit lasting approximately 2 and a half hours.
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Clinical Science Centre, Aintree University Hospital
Study officials:
affiliation: The University of Liverpool
name: Uazman Alam, PhD
role: PRINCIPAL_INVESTIGATOR
References: