Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Left Ventricular Dysfunction
• Intervention / Treatment: Diagnostic test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarker

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Dalong Zhu, MD,PhD; Phone Number: 61431 86-025-83106666; Email: zhudalong@nju.edu.cn
• Study Contact Backup: Name: Ran Meng, MD,PhD; Phone Number: 61431 86-025-83106666; Email: 179622242@qq.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
      • Contact: Dalong Zhu, MD.PhD.; Phone Number: 61431 86-025-83106666; Email: zhudalong@nju.edu.cn
      • Contact: Ran Meng, MD.PhD; Phone Number: 61431 86-025-83106666; Email: 179622242@qq.com
      • Principal Investigator: Dalong Zhu, MD.PhD
      • Sub-Investigator: Ran Meng, MD.PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal cardiac function groups; 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; 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
Impaired cardiac function groups; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography	Proportion of participants with GLS>-18% in percent	Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 17, 2022
• First Submitted That Met QC Criteria: July 30, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Left Ventricular Dysfunction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Ventricular Dysfunction; Ventricular Dysfunction, Left; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: DCM2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No