Chinese Endocrinologists Health Education Study

Type 2 Diabetes Clinical Trial

— CREATION  

Official title:

Chinese Endocrinologists Health Education Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05715307
• Other study ID #: CCEMD2022001
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Yifei Zhang, M.D. Ph.D.
• Phone: 86-021-64370045
• Email: feifei-a[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In the first phase (Phase I), about 200 eligible endocrinologists from National Metabolic Management Centers (MMC) (one endocrinologist in each center) will be randomized (1:1) into two groups after screening. Two groups will receive 1-week intensive experiential training in the MMC leading center (Ruijin Hospital) for T2DM management or regular MMC working training, respectively. In the second phase (Phase II) , each endocrinologist is required to manage a certain number of T2DM patients (n≈10). The total number of patients in the intensive training group and the regular training group is approximately 1000:1000. Metabolic parameters including weight, glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), fasting and postprandial insulin, blood pressure and lipid levels will be measured. Furthermore, the change of patients' quality of life and endocrinologists' prescribing habits will be evaluated. The primary objective is to determine whether an 1-week intensive experiential training in T2DM management for MMC endocrinologists has a positive effect in patients' HbA1c control rate (percentage of patients achieving HbA1c <7.0%) after 6-month management. The secondary objective is to explore the effect of intensive training on other metabolic parameters, patients' quality of life and endocrinologists' prescribing habits after 6-month and 12-month management.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Other:
• Intensive experiential training in T2DM management
One-week intensive experiential training for endocrinologists, means 1-week hospitalization experience in leading center (Ruijin Hospital) including health examination and results interpretation, and attending integrated training courses for T2DM management. During patient intervention period, endocrinologists will attend the follow-up and experience sharing meeting regularly.
• Regular training in T2DM management
Regular training and communication implemented by MMC leading center (Ruijin Hospital) under the guidance of T2DM diagnosis and treatment.

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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