Diabetes MellitusNCT05484817
Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus
An observational study of Diabetes Mellitus and Left Ventricular Dysfunction, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Left Ventricular Dysfunction
- What is being tested?
- Assessment of cardiovascular risk factor, endocrine hormones and related biomarker
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Male or Female, aged ≥18 and ≤80 years.
- Diagnosed type 2 or type 1 diabetes
Who cannot join
- Moderate or severe valvular heart disease, history of thoracic surgery or congenital heart disease，atrial fibrillation.
- History of coronary heart disease or stroke
- Typical symptoms of cardiovascular disease（angina pectoris or limiting dyspnoea (>NYHA II)）
- LVEF <60％
- Malignant tumor, acute infection, abnormal liver and kidney function (ALT > normal upper limit 3 times or eGFR < 60 ml/min/1.73 m2)
- Diabetic ketoacidosis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Dalong Zhu, MD.PhD., 86-025-83106666 ext. 61431, zhudalong@nju.edu.cn
Ran Meng, MD.PhD, 86-025-83106666 ext. 61431, 179622242@qq.com
About this study
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.
Read the 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:
- 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.
- Conditions
- Diabetes Mellitus, Left Ventricular Dysfunction
- Being tested
- Assessment of cardiovascular risk factor, endocrine hormones and related biomarker
- Keywords
- Diabetes Mellitus, Left Ventricular Dysfunction
- Medical subject headings
- Diabetes Mellitus, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of cardiovascular risk factor, endocrine hormones and related biomarkerDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: Diagnostic Test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarker | |
| 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%. Receives: Diagnostic Test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography
Proportion of participants with GLS>-18% in percent
Measured: Day 1
Secondary outcomes (24)
Participants' personal information by questionnaire
Self-reported information(history of smoking)
Measured: Day 1
BMI by physical assessments
BMI(body mass index) in kg/m^2
Measured: Day 1
Waist by physical assessments
Waist in kg/m^2
Measured: Day 1
Systolic blood pressure by physical assessments
Systolic blood pressure in mmHg
Measured: Day 1
Diastolic blood pressure by physical assessments
Diastolic blood pressure in mmHg
Measured: Day 1
Glycaemic control measured by blood test
HbA1c in %
Measured: Day 1
Fasting glucose by blood test
Fasting glucose in mmol/l
Measured: Day 1
Islet function measured by blood test
Fasting C-peptide in pmol/l
Measured: Day 1
Glycaemic control measured by Continuous Glucose Monitoring System
Time in range in percent
Measured: Day 1 - Day 14
High density lipoprotein cholesterol by blood test
High density lipoprotein cholesterol in mmol/l
Measured: Day 1
Low density lipoprotein cholesterol by blood test
Low density lipoprotein cholesterol in mmol/l
Measured: Day 1
Total cholesterol by blood test
Total cholesterol in mmol/l
Measured: Day 1
Triglycerides measured by blood test
Triglycerides in mmol/l
Measured: 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
Measured: Day 13-Day 14
Uric acids measured by blood test
Uric acids in umol/l
Measured: Day 1
Bone metabolism hormones measured by blood test
Osteocalcin in ng/ml
Measured: Day 1
Estradiol measured by blood test
Estradiol in pmol/l
Measured: Day 1
Testosterone measured by blood test
Testosterone in nmol/l
Measured: Day 1
Luteinizing hormone measured by blood test
Luteinizing hormone in mIU/ml
Measured: Day 1
Follicle-stimulating hormone measured by blood test
Follicle-stimulating Hormone in mIU/ml
Measured: Day 1
Insulin-like growth factor 1 measured by blood test
Insulin-like growth factor 1 in ng/ml
Measured: Day 1
Cortisol measured by blood test
Cortisol in nmol/l
Measured: Day 1
Adrenocorticotropic-hormone measured by blood test
Adrenocorticotropic-hormone in pmol/l
Measured: Day 1
Biomarker measured by blood test
Brain natriuretic peptide in pg/ml
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Jun 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Dalong Zhu, MD,PhD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484817
- Sponsor's protocol ID
- DCM2022
- Status last verified
- Aug 2022
- First submitted
- 17 Jul 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05484817
- Acronym / sponsor ID
- DCM2022
- Conditions
- Diabetes Mellitus, Left Ventricular Dysfunction
- Keywords
- Diabetes Mellitus, Left Ventricular Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal cardiac function groups | – | Diagnostic Test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarkerPatients 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%. |
| Impaired cardiac function groups | – | Diagnostic Test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarkerPatients 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%. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Male or Female, aged ≥18 and ≤80 years.
- Diagnosed type 2 or type 1 diabetes
Key exclusion criteria (7 listed)
- Moderate or severe valvular heart disease, history of thoracic surgery or congenital heart disease，atrial fibrillation.
- History of coronary heart disease or stroke
- Typical symptoms of cardiovascular disease（angina pectoris or limiting dyspnoea (>NYHA II)）
- LVEF <60％
- Malignant tumor, acute infection, abnormal liver and kidney function (ALT > normal upper limit 3 times or eGFR < 60 ml/min/1.73 m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of cardiovascular risk factor, endocrine hormones and related biomarkerCardiovascular 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 | Diagnostic test | Impaired cardiac function groups, Normal cardiac function groups |
Primary outcome
Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography
Time frame: Day 1
Proportion of participants with GLS>-18% in percent
24 secondary outcomes
Participants' personal information by questionnaire
Time frame: Day 1
BMI by physical assessments
Time frame: Day 1
Waist by physical assessments
Time frame: Day 1
Systolic blood pressure by physical assessments
Time frame: Day 1
Diastolic blood pressure by physical assessments
Time frame: Day 1
Glycaemic control measured by blood test
Time frame: Day 1
Fasting glucose by blood test
Time frame: Day 1
Islet function measured by blood test
Time frame: Day 1
Glycaemic control measured by Continuous Glucose Monitoring System
Time frame: Day 1 - Day 14
High density lipoprotein cholesterol by blood test
Time frame: Day 1
Low density lipoprotein cholesterol by blood test
Time frame: Day 1
Total cholesterol by blood test
Time frame: Day 1
Triglycerides measured by blood test
Time frame: Day 1
Masked hypertension diagnosed by ambulatory blood pressure monitoring
Time frame: Day 13-Day 14
Uric acids measured by blood test
Time frame: Day 1
Bone metabolism hormones measured by blood test
Time frame: Day 1
Estradiol measured by blood test
Time frame: Day 1
Testosterone measured by blood test
Time frame: Day 1
Luteinizing hormone measured by blood test
Time frame: Day 1
Follicle-stimulating hormone measured by blood test
Time frame: Day 1
Insulin-like growth factor 1 measured by blood test
Time frame: Day 1
Cortisol measured by blood test
Time frame: Day 1
Adrenocorticotropic-hormone measured by blood test
Time frame: Day 1
Biomarker measured by blood test
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalong Zhu, MD,PhD principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Left Ventricular Dysfunction, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalong Zhu, MD,PhD (86-025-83106666 ext. 61431, zhudalong@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.