Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus

• Conditions: Left Ventricular Dysfunction; Diabetes Mellitus

• Registration Number: NCT05484817
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-07-17
• Study First Submitted QC: 2022-07-30
• Status Verified: 2022-08
• Study First Posted: 2022-08-02
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-05
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography	Day 1	Proportion of participants with GLS\>-18% in percent

Secondary Outcome Measures

Name	Time	Method
BMI by physical assessments	Day 1	BMI(body mass index) in kg/m\^2
Islet function measured by blood test	Day 1	Fasting C-peptide in pmol/l
Diastolic blood pressure by physical assessments	Day 1	Diastolic blood pressure in mmHg
Participants' personal information by questionnaire	Day 1	Self-reported information(history of smoking)
Glycaemic control measured by Continuous Glucose Monitoring System	Day 1 - Day 14	Time in range in percent
Low density lipoprotein cholesterol by blood test	Day 1	Low density lipoprotein cholesterol in mmol/l
Total cholesterol by blood test	Day 1	Total cholesterol in mmol/l
Uric acids measured by blood test	Day 1	Uric acids in umol/l
Waist by physical assessments	Day 1	Waist in kg/m\^2
Systolic blood pressure by physical assessments	Day 1	Systolic blood pressure in mmHg
Glycaemic control measured by blood test	Day 1	HbA1c in %
Triglycerides measured by blood test	Day 1	Triglycerides in mmol/l
Bone metabolism hormones measured by blood test	Day 1	Osteocalcin in ng/ml
Estradiol measured by blood test	Day 1	Estradiol in pmol/l
Testosterone measured by blood test	Day 1	Testosterone in nmol/l
Adrenocorticotropic-hormone measured by blood test	Day 1	Adrenocorticotropic-hormone in pmol/l
High density lipoprotein cholesterol by blood test	Day 1	High density lipoprotein cholesterol in mmol/l
Masked hypertension diagnosed by ambulatory blood pressure monitoring	Day 13-Day 14	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
Luteinizing hormone measured by blood test	Day 1	Luteinizing hormone in mIU/ml
Follicle-stimulating hormone measured by blood test	Day 1	Follicle-stimulating Hormone in mIU/ml
Insulin-like growth factor 1 measured by blood test	Day 1	Insulin-like growth factor 1 in ng/ml
Biomarker measured by blood test	Day 1	Brain natriuretic peptide in pg/ml
Fasting glucose by blood test	Day 1	Fasting glucose in mmol/l
Cortisol measured by blood test	Day 1	Cortisol in nmol/l

Trial Locations

Locations (1)

The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China