Clinical Science Centre, Aintree University Hospital
Liverpool, L9 7AL, United Kingdom
NCT Number: NCT06053177
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.
This study is active but is not currently recruiting participants.
18 year–90 year
All sexes
Observational
Liverpool, L9 7AL, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Type 2 diabetes study group
Prediabetes study group
Exclusion criteria
Time frame: 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.
Time frame: 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).
Time frame: 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.
University of Liverpool
Other
Primary Care Screening to Rapidly Detect Multi-organ Complications for People With Prediabetes and Type 2 Diabetes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01586442
Cardiovascular Diseases, Diabetes Mellitus
Montreal, Quebec, Canada
View Trial DetailsNCT07390110
Cardiovascular Diseases, Diabetes Mellitus
Boston, Massachusetts, United States
View Trial DetailsNCT06980623
Cardiovascular Diseases, Diabetes Mellitus
Boston, Massachusetts, United States
View Trial DetailsNCT05705869
Autoimmune Diseases, Cardiovascular Diseases
Glasgow, Scotland, United Kingdom
View Trial Details