Clinical trial NCT05715307: Chinese Endocrinologists Health Education Study
Official title: Chinese Endocrinologists Health Education Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 2017
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a prospective, multicenter, cluster randomized control study, to evaluate the improvement for T2DM treatment ability in Chinese endocrinologists after 1-week intensive experiential diabetes management training in Ruijin Hospital.

Detailed description: The primary objective is to determine whether a 1-week intensive experiential training in T2DM management for MMC endocrinologists has a positive effect on 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 experiential training on other metabolic parameters, patients' quality of life and endocrinologists' prescribing habits after 6-month and 12-month management.

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. Intensive training group will receive a 1-week intensive experiential training in the MMC leading center (Ruijin Hospital) for T2DM management, and control group will receive regular MMC working training. In the second phase (Phase II) , each endocrinologist will be required to manage a certain number of T2DM patients (n≈10). The total number of patients in the intensive training group and the control group will be approximately 1000:1000. Metabolic parameters including weight, body mass index (BMI), waist circumference, hip circumference, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glycated haemoglobin (HbA1c) control rate
timeFrame: 6 months
Secondary outcomes:
measure: Glycated haemoglobin (HbA1c)
timeFrame: 6 and 12 months
measure: Systolic and diastolic blood pressure
timeFrame: 6 and 12 months
measure: Body weight
timeFrame: 6 and 12 months
measure: Waist circumference
timeFrame: 6 and 12 months
measure: Hip circumference
timeFrame: 6 and 12 months
measure: Fasting blood glucose levels
timeFrame: 6 and 12 months
measure: 2-hour post-prandial blood glucose levels
timeFrame: 6 and 12 months
measure: Fasting serum insulin levels
timeFrame: 6 and 12 months
measure: 2-hour post-prandial serum insulin levels
timeFrame: 6 and 12 months
measure: Serum triglycerides
timeFrame: 6 and 12 months
measure: Serum total cholesterol
timeFrame: 6 and 12 months
measure: Serum low density lipoprotein cholesterol (LDL-c)
timeFrame: 6 and 12 months
measure: Quality of life (QoL)
timeFrame: 6 and 12 months
measure: Glycated haemoglobin (HbA1c) control rate
timeFrame: 12 months
measure: Prescribing habits of doctors
timeFrame: 12 months
measure: Diabetes knowledge of doctors
timeFrame: 12 months
measure: Adverse events
timeFrame: 1, 3, 6, 9, 12 months
measure: Pulse rate
timeFrame: 1, 3, 6, 9, 12 months
measure: White blood cell count
timeFrame: 12 months
measure: Red blood cell count
timeFrame: 12 months
measure: Hemoglobin levels
timeFrame: 12 months
measure: Platelet count
timeFrame: 12 months
measure: Number of participants with abnormal Urine routine
timeFrame: 12 months
measure: Number of participants with abnormal Hepatic function
timeFrame: 3, 6, 9, 12 months
measure: Number of participants with abnormal Renal function
timeFrame: 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: