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Diabetic cardiomyopathy: predictors of progression and outcome after 10 years of follow up.

Diabetic cardiomyopathy: predictors of progression and outcome after 10 years of follow up. A ten year follow up of participants in an earlier original research study by the same group which studied a large cohort of type II diabetes patients, looking for early identification of cardiomyopathy.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12612001178831
Enrollment
200
Registered
2012-11-06
Start date
2013-08-15
Completion date
2014-08-20
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Type 2 diabetes mellitus (T2DM) is the fastest growing chronic disease in Australia today with an estimated 275 new cases every day. Currently 1.7 million Australians have diabetes and it is thought that up to half of these individuals are as yet undiagnosed. The annual cost of diabetes to the Australian healthcare system is estimated at least $3 billion. Diabetes was the underlying cause for 3.0% deaths registered in Australia in 2009 and additionally contributed to 10.1% deaths as either an underlying or associated cause of death. Worldwide it is anticipated that by the year 2025 there will be 300 million people with the disease especially given the epidemic of obesity and impact of sedentary lifestyles. It is known that individuals with diabetes have a significantly increased risk of cardiovascular disease. Recent data showed that this condition is underappreciated with 48% of all diabetic individuals, who had no previous history of structural heart disease, having evidence of Diabetic Cardiomyopathy echocardiographically. In diabetics, a complex series of metabolic disturbances results in heart fibrosis and enlargement. which ultimately leads to clinical heart failure. Despite 4 decades of research there are currently no specific treatments for diabetic cardiomyopathy. Prevention of this condition requires its early identification and treatment. Early treatment with medications known to improve heart failure outcome such as angiotensin-converting enzyme inhibitors (ACEI) and beta-blockers has been suggested from meta-analysis data specifically looking at diabetic subjects in the major heart failure trials to be beneficial . There is yet to be a long term follow-up study to definitively confirm this. Much of the previous work focusing on the early identification of this condition has been carried out by the Cardiovascular Imaging Research group through involvement in an NHMRC Centre of Clinical Research Excellence Award (455832). Work initiated in 2003 studied a large cohort of T2DM patients in a randomized controlled trial of lifestyle intervention. The results of this research were groundbreaking, proving that diabetic cardiomyopathy was able to be identified using novel echocardiographic imaging techniques. The proposed project aims to provide long term (10 year) follow up data on these original participants. To our knowledge this will be unique data within the literature allowing identification of markers of long term adverse prognosis and information about the factors affecting the progression of diabetic cardiomyopathy over time. Hypotheses The following hypotheses will be tested: 1. Diabetic cardiomyopathy is prevalent and progressive over time. Clinical and widely available testing including echocardiography and cardiopulmonary exercise testing is able to identify long term risk markers for diabetic cardiomyopathy which result in adverse cardiovascular morbidity and mortality. 2. Novel echocardiographic techniques, are superior to current echocardiographic techniques for the detection of diabetic cardiomyopathy and are better able to assess cardiac risk as evidenced by subclinical left ventricular dysfunction. 3. ACE inhibitor/Angiotensin Receptor Blocker (ARB) therapy and/or beta-blocker therapy will prevent the progression of DCM over long term follow-up.

Interventions

10 year follow up to assess development of cardiomyopathy in diabetic patients. Participation involves: *Measurement of height, weight, waist circumference and blood pressure Fasting blood test * Cardiac echocardiograph test, including a carotid artery ultrasound scan *An exercise stress test (if participants are able to exercise) *Participants will also be asked to provide a list to the study staff of all medications, including the length of time each medication has been taken. The testing wi

10 year follow up to assess development of cardiomyopathy in diabetic patients. Participation involves: *Measurement of height, weight, waist circumference and blood pressure Fasting blood test * Cardiac echocardiograph test, including a carotid artery ultrasound scan *An exercise stress test (if participants are able to exercise) *Participants will also be asked to provide a list to the study staff of all medications, including the length of time each medication has been taken. The testing will be arranged to take place in one 2 hour session.

Sponsors

Dr Tony Stanton
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

Participation will be invited from all surviving participants of the original study commenced in 2003. Inclusion criteria: -Age >18 years, and <85 years -Diagnosed with type 2 diabetes -Appropriate informed consent obtained and signed

Exclusion criteria

-Patients unwilling to comply with frequent follow-up -Patients currently enrolled in another investigational study -Patients whose life expectancy is severely limited due to pre-existing malignancy or other disease (< 6 months) -Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026