An observational study in Diabetes Mellitus and Left Ventricular Dysfunction, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational
This is a single-center, prospective, observational study to explore the clinical features and risk factors of impaired cardiac function detected by two-dimensional speckle tracking echocardiography in patients with diabetes mellitus. The risk factors include traditional cardiovascular risk factors, bone metabolism hormones, sex hormones, adrenal and pituitary hormones, and novel serum biomarkers.
Cardiovascular complications are a leading cause of death in patients with diabetes mellitus. However, early cardiovascular disease screening presents several challenges, particularly for those who have no cardiovascular symptoms. Novel imaging techniques, such as tissue Doppler imaging and speckle tracking echocardiography, allow for the more frequent detection of early subclinical left ventricular systolic dysfunction in asymptomatic patients with diabetes. Based on speckle tracking echocardiography and other techniques, this study evaluated cardiovascular function in diabetic subjects to achieve the following objectives:
A) Investigate the clinical characteristics of diabetic patients with early cardiovascular function impairment. B) Investigate the role of traditional cardiovascular risk factors, bone metabolism hormones, sex hormones, adrenal and pituitary hormones in diabetic patients with early cardiovascular function impairment. C) Explore novel biomarkers of early cardiovascular dysfunction in diabetic patients.
262 studies on the registry are indexed under Ventricular Dysfunction; 40 are open to participants now.
This study's planned enrollment of 300 is above the median of 104 across 111 observational studies indexed under Ventricular Dysfunction.
Browse Ventricular Dysfunction studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be adults admitted to the hospital or recruited from the community with type 2 or type 1 diabetes. All patients has no medical history of known cardiovascular disease.
Exclusion Criteria:
Patients admitted to the hospital or recruited from the community with diabetes mellitus are screened for cardiovascular diseases by echocardiography. Global longitudinal strain (GLS) is measured by speckle tracking echocardiography. The 2015 American Society of Echocardiography guidelines recommended a mean of -20% for GLS in healthy subjects, while the upper normal limit is -18%. Therefore, the normal cardiac function groups are defined as GLS \< -18%.
Diagnostic Test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarker
Patients admitted to the hospital or recruited from the community with diabetes mellitus are screened for cardiovascular diseases by echocardiography. Global longitudinal strain (GLS) is measured by speckle tracking echocardiography. The 2015 American Society of Echocardiography guidelines recommended a mean of -20% for GLS in healthy subjects, while the upper normal limit is -18%. Therefore, the impaired cardiac function groups are defined as GLS ≥ -18%.
Diagnostic Test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarker
Cardiovascular risk factors: glycated hemoglobin/C-peptide/continuous glucose monitoring/blood pressure, blood lipids, uric acid, microalbumin test, etc. Endocrin hormones: bone metabolism, sex hormones, adrenal and pituitary hormones, and related biomarkers
Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography
Proportion of participants with GLS\>-18% in percent
Time frame: Day 1
Participants' personal information by questionnaire
Self-reported information(history of smoking)
Time frame: Day 1
BMI by physical assessments
BMI(body mass index) in kg/m\^2
Time frame: Day 1
Waist by physical assessments
Waist in kg/m\^2
Time frame: Day 1
Systolic blood pressure by physical assessments
Systolic blood pressure in mmHg
Time frame: Day 1
Diastolic blood pressure by physical assessments
Diastolic blood pressure in mmHg
Time frame: Day 1
Glycaemic control measured by blood test
HbA1c in %
Time frame: Day 1
Fasting glucose by blood test
Fasting glucose in mmol/l
Time frame: Day 1
Islet function measured by blood test
Fasting C-peptide in pmol/l
Time frame: Day 1
Glycaemic control measured by Continuous Glucose Monitoring System
Time in range in percent
Time frame: Day 1 - Day 14
High density lipoprotein cholesterol by blood test
High density lipoprotein cholesterol in mmol/l
Time frame: Day 1
Low density lipoprotein cholesterol by blood test
Low density lipoprotein cholesterol in mmol/l
Time frame: Day 1
Total cholesterol by blood test
Total cholesterol in mmol/l
Time frame: Day 1
Triglycerides measured by blood test
Triglycerides in mmol/l
Time frame: Day 1
Masked hypertension diagnosed by ambulatory blood pressure monitoring
Proportion of participants with a clinical condition in which a patient's office blood pressure (BP) level is \<140/90 mm Hg but ambulatory BP readings are in the hypertensive range in percent
Time frame: Day 13-Day 14
Uric acids measured by blood test
Uric acids in umol/l
Time frame: Day 1
Bone metabolism hormones measured by blood test
Osteocalcin in ng/ml
Time frame: Day 1
Estradiol measured by blood test
Estradiol in pmol/l
Time frame: Day 1
Testosterone measured by blood test
Testosterone in nmol/l
Time frame: Day 1
Luteinizing hormone measured by blood test
Luteinizing hormone in mIU/ml
Time frame: Day 1
Follicle-stimulating hormone measured by blood test
Follicle-stimulating Hormone in mIU/ml
Time frame: Day 1
Insulin-like growth factor 1 measured by blood test
Insulin-like growth factor 1 in ng/ml
Time frame: Day 1
Cortisol measured by blood test
Cortisol in nmol/l
Time frame: Day 1
Adrenocorticotropic-hormone measured by blood test
Adrenocorticotropic-hormone in pmol/l
Time frame: Day 1
Biomarker measured by blood test
Brain natriuretic peptide in pg/ml
Time frame: Day 1
Plan to share: Undecided
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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School