Type 2 Diabetes Clinical Trial
— CREATIONOfficial title:
Chinese Endocrinologists Health Education Study
The purpose of this study is to conduct a prospective, multicenter, cluster randomized control study, evaluating the improvement for T2DM diagnosis and treatment ability in Chinese endocrinologists after 1-week intensive experiential diabetes management training in the leading center.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | September 1, 2024 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility | Inclusion Criteria: - 1. Subjects with type 2 diabetes mellitus; - 2. First visit to MMC; - 3. Age 40-65 years; - 4. 24.0 < BMI = 35.0 kg/m2; - 5. Subjects with screening HbA1c = 7.5% and = 10.0%, and the fasting blood glucose = 8.0 mmol/l and = 13.3 mmol/l; - 6. Duration of diabetes less than 10 years; - 7. Subjects with poorly controlled blood glucose only by 1-2 kinds of non-insulin hypoglycemic drugs for at least 2 months; - 8. Subjects understand the nature, significance, potential benefits, inconvenience, and risks of the study before it starts, and fully understand the study procedures and voluntarily sign the informed consent form. Exclusion Criteria: - 1. Subjects with type 1 diabetes, single gene mutation diabetes, diabetes due to pancreatic injury or other secondary diabetes (such as Cushing's syndrome, thyroid dysfunction or acromegaly, etc.); - 2. Subjects with serious cardiovascular diseases, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy and chronic congestive heart failure (NYHA III-IV); acute myocarditis within 12 months; severe liver and kidney dysfunction (eGFR<60mL/min/1.73m2); mental disorder, etc. - 3. Subjects with acute diabetic complications in the past 3 months; - 4. Subjects who were or are using insulin to control diabetes in the past 3 months; - 5. History of drug abuse; - 6. History of sexually transmitted disease (such as syphilis, and HIV infection [AIDS], etc.) or in the active phase of infectious disease (such as viral hepatitis, and tuberculosis, etc.); - 7. Subjects who are pregnant or in lactation; - 8. Participation in other clinical trials; - 9. Any condition that in the judgement of the investigator precludes participation. Details please see the study protocol. |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glycated haemoglobin (HbA1c) control rate | percentage of patients achieving HbA1c <7.0% | 6 months | |
Secondary | Glycated haemoglobin (HbA1c) | 6 and 12 months | ||
Secondary | Systolic and diastolic blood pressure | 6 and 12 months | ||
Secondary | Body weight | Body weight (Kg) or Body Mass Index (Kg/m2) | 6 and 12 months | |
Secondary | Waist circumference | 6 and 12 months | ||
Secondary | Hip circumference | 6 and 12 months | ||
Secondary | Fasting blood glucose levels | 6 and 12 months | ||
Secondary | 2-hour post-prandial blood glucose levels | 6 and 12 months | ||
Secondary | Fasting serum insulin levels | 6 and 12 months | ||
Secondary | 2-hour post-prandial serum insulin levels | 6 and 12 months | ||
Secondary | Serum triglycerides | 6 and 12 months | ||
Secondary | Serum total cholesterol | 6 and 12 months | ||
Secondary | Serum low density lipoprotein cholesterol (LDL-c) | 6 and 12 months | ||
Secondary | Quality of life (QoL) | Quality of life will be assessed by self-reported questionnaire. | 6 and 12 months | |
Secondary | Glycated haemoglobin (HbA1c) control rate | percentage of patients achieving HbA1c <7.0% | 12 months | |
Secondary | Prescribing habits of doctors | Prescribing habits including use of hypoglycemic, lipid-lowering and antihypertensive drugs measured will be assessed through standardized questionnaire. | 12 months | |
Secondary | Diabetes knowledge of doctors | Diabetes knowledge of doctors will be assessed through self-reported questionnaire. | 12 months | |
Secondary | Adverse events | Safety outcomes | 1, 3, 6, 9, 12 months | |
Secondary | Pulse rate | Safety outcomes. | 1, 3, 6, 9, 12 months | |
Secondary | White blood cell count | Safety outcomes. | 12 months | |
Secondary | Red blood cell count | Safety outcomes. | 12 months | |
Secondary | Hemoglobin levels | Safety outcomes. | 12 months | |
Secondary | Platelet count | Safety outcomes. | 12 months | |
Secondary | Number of participants with abnormal Urine routine | Safety outcomes. Including urine protein, urine glucose, urine leukocytes, urinary ketone bodies and urine erythrocytes. | 12 months | |
Secondary | Number of participants with abnormal Hepatic function | Safety outcomes. Including aspartate aminotransferase, alanine aminotransferase, direct bilirubin, total bilirubin, albumin, total protein, alkaline phosphatase and ?-glutamyltransferase. | 3, 6, 9, 12 months | |
Secondary | Number of participants with abnormal Renal function | Safety outcomes. Including serum urea nitrogen, serum creatinine, and serum urinary acid. | 3, 6, 9, 12 months |
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