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

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ClinicalTrials.gov Identifier: NCT06053177
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : September 25, 2023
Sponsor:
Information provided by (Responsible Party):
University of Liverpool

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

Study Design
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Study Type : Observational
Estimated 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 : January 25, 2023
Estimated Primary Completion Date : February 3, 2025
Estimated Study Completion Date : February 3, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Groups and Cohorts
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Group/Cohort
Type 2 Diabetes
Participants with type 2 diabetes
Pre Diabetes
Participants who's most recent HbA1c is in the prediabetes range.


Outcome Measures
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Primary Outcome Measures :
  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 [ 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.


Secondary Outcome Measures :
  1. Peripheral neuropathy and cardiac autonomic dysfunction [ 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).

  2. Multi-morbidity screening [ 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06053177


Contacts
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Contact: David R Riley, MBBS 0151 529 5917 identify@liverpool.ac.uk
Contact: Uazman Alam, PhD 0151 529 5918 ualam@liverpool.ac.uk

Locations
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United Kingdom
Clinical Science Centre, Aintree University Hospital Recruiting
Liverpool, United Kingdom, L9 7AL
Contact: David R Riley, MBBS    0151 529 5917    identify@liverpool.ac.uk   
Sponsors and Collaborators
University of Liverpool
Investigators
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Principal Investigator: Uazman Alam, PhD The University of Liverpool
More Information
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Responsible Party: University of Liverpool
ClinicalTrials.gov Identifier: NCT06053177    
Other Study ID Numbers: UoL001691
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Liverpool:
screening
multi-morbidity
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Sleep Apnea, Obstructive
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Digestive System Diseases
Hyperglycemia