Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05484817
• Other study ID #: DCM2022
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: September 2023

Study information

• Verified date: August 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Dalong Zhu, MD,PhD
• Phone: 86-025-83106666
• Email: zhudalong[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Left Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

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

Locations

Country	Name	City	State
China	The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography	Proportion of participants with GLS>-18% in percent	Day 1
Secondary	Participants' personal information by questionnaire	Self-reported information(history of smoking)	Day 1
Secondary	BMI by physical assessments	BMI(body mass index) in kg/m^2	Day 1
Secondary	Waist by physical assessments	Waist in kg/m^2	Day 1
Secondary	Systolic blood pressure by physical assessments	Systolic blood pressure in mmHg	Day 1
Secondary	Diastolic blood pressure by physical assessments	Diastolic blood pressure in mmHg	Day 1
Secondary	Glycaemic control measured by blood test	HbA1c in %	Day 1
Secondary	Fasting glucose by blood test	Fasting glucose in mmol/l	Day 1
Secondary	Islet function measured by blood test	Fasting C-peptide in pmol/l	Day 1
Secondary	Glycaemic control measured by Continuous Glucose Monitoring System	Time in range in percent	Day 1 - Day 14
Secondary	High density lipoprotein cholesterol by blood test	High density lipoprotein cholesterol in mmol/l	Day 1
Secondary	Low density lipoprotein cholesterol by blood test	Low density lipoprotein cholesterol in mmol/l	Day 1
Secondary	Total cholesterol by blood test	Total cholesterol in mmol/l	Day 1
Secondary	Triglycerides measured by blood test	Triglycerides in mmol/l	Day 1
Secondary	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	Day 13-Day 14
Secondary	Uric acids measured by blood test	Uric acids in umol/l	Day 1
Secondary	Bone metabolism hormones measured by blood test	Osteocalcin in ng/ml	Day 1
Secondary	Estradiol measured by blood test	Estradiol in pmol/l	Day 1
Secondary	Testosterone measured by blood test	Testosterone in nmol/l	Day 1
Secondary	Luteinizing hormone measured by blood test	Luteinizing hormone in mIU/ml	Day 1
Secondary	Follicle-stimulating hormone measured by blood test	Follicle-stimulating Hormone in mIU/ml	Day 1
Secondary	Insulin-like growth factor 1 measured by blood test	Insulin-like growth factor 1 in ng/ml	Day 1
Secondary	Cortisol measured by blood test	Cortisol in nmol/l	Day 1
Secondary	Adrenocorticotropic-hormone measured by blood test	Adrenocorticotropic-hormone in pmol/l	Day 1
Secondary	Biomarker measured by blood test	Brain natriuretic peptide in pg/ml	Day 1