Clinical trial NCT05484817: Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus
Official title: Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Left Ventricular Dysfunction
Keywords: Diabetes Mellitus
Left Ventricular Dysfunction
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or Female, aged ≥18 and ≤80 years.
2. Diagnosed type 2 or type 1 diabetes

Exclusion Criteria:

1. Moderate or severe valvular heart disease, history of thoracic surgery or congenital heart disease，atrial fibrillation.
2. History of coronary heart disease or stroke
3. Typical symptoms of cardiovascular disease（angina pectoris or limiting dyspnoea (\>NYHA II)）
4. LVEF \<60％
5. Malignant tumor, acute infection, abnormal liver and kidney function (ALT \> normal upper limit 3 times or eGFR \< 60 ml/min/1.73 m2)
6. Diabetic ketoacidosis
7. Pregnancy

Primary outcomes:
measure: Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography
timeFrame: Day 1
Secondary outcomes:
measure: Participants' personal information by questionnaire
timeFrame: Day 1
measure: BMI by physical assessments
timeFrame: Day 1
measure: Waist by physical assessments
timeFrame: Day 1
measure: Systolic blood pressure by physical assessments
timeFrame: Day 1
measure: Diastolic blood pressure by physical assessments
timeFrame: Day 1
measure: Glycaemic control measured by blood test
timeFrame: Day 1
measure: Fasting glucose by blood test
timeFrame: Day 1
measure: Islet function measured by blood test
timeFrame: Day 1
measure: Glycaemic control measured by Continuous Glucose Monitoring System
timeFrame: Day 1 - Day 14
measure: High density lipoprotein cholesterol by blood test
timeFrame: Day 1
measure: Low density lipoprotein cholesterol by blood test
timeFrame: Day 1
measure: Total cholesterol by blood test
timeFrame: Day 1
measure: Triglycerides measured by blood test
timeFrame: Day 1
measure: Masked hypertension diagnosed by ambulatory blood pressure monitoring
timeFrame: Day 13-Day 14
measure: Uric acids measured by blood test
timeFrame: Day 1
measure: Bone metabolism hormones measured by blood test
timeFrame: Day 1
measure: Estradiol measured by blood test
timeFrame: Day 1
measure: Testosterone measured by blood test
timeFrame: Day 1
measure: Luteinizing hormone measured by blood test
timeFrame: Day 1
measure: Follicle-stimulating hormone measured by blood test
timeFrame: Day 1
measure: Insulin-like growth factor 1 measured by blood test
timeFrame: Day 1
measure: Cortisol measured by blood test
timeFrame: Day 1
measure: Adrenocorticotropic-hormone measured by blood test
timeFrame: Day 1
measure: Biomarker measured by blood test
timeFrame: Day 1
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Dalong Zhu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: