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임상시험 NCT05484817은(는) 당뇨병, 좌심실 기능 장애에 대해 미상 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus 300 바이오마커 기반 관찰 연구 신규 요법
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT05484817은(는) 당뇨병, 좌심실 기능 장애에 대해 알아보는 관찰연구입니다. 현재 상태는 미상이며, 연구는 2022년 6월 1일에 시작되어 300명의 참여자를 모집하고 있습니다. The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School이(가) 진행하며, 2023년 9월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2022년 8월 5일에 갱신되었습니다.
간단한 개요
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.
상세한 설명
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 dysfunct...더 보기
공식 제목
Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus
질환명
당뇨병좌심실 기능 장애기타 연구 식별자
- DCM2022
NCT 번호
실제 연구 시작일
2022-06-01
최신 업데이트 게시
2022-08-05
예상 연구 완료일
2023-09
계획된 등록 인원
300
연구종류
관찰연구
상태
미상
키워드
Diabetes Mellitus
Left Ventricular Dysfunction
Left Ventricular Dysfunction
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
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 funct...더 보기 | 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 fun...더 보기 | 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 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography | Proportion of participants with GLS\>-18% in percent | Day 1 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Male or Female, aged ≥18 and ≤80 years.
- Diagnosed type 2 or type 1 diabetes
- 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
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School연구 책임자
Dalong Zhu, 책임연구자, Chief Physician , Principal Investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
연구 대표 연락처
연락처: Dalong Zhu, MD,PhD, 86-025-83106666, [email protected]
연락처: Ran Meng, MD,PhD, 86-025-83106666, [email protected]
1 1개국에 임상시험 장소
Jiangsu
The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, 210008, China
Dalong Zhu, MD.PhD., 연락처, 86-025-83106666, [email protected]
Ran Meng, MD.PhD, 연락처, 86-025-83106666, [email protected]
Dalong Zhu, MD.PhD, 책임연구자
Ran Meng, MD.PhD, 공동연구자
모집중