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Evaluation of the effectiveness of comprehensive non-pharmacological treatment on metabolic disorders in type 2 diabetic patients
Patients in the intervention group will participate in a comprehensive non-pharmacological treatment of type 2 diabetes, the main components are:
Patients in the control group will not participate in group sessions, but they had the opportunity to receive non-pharmacological care provided in the framework of free outpatient care. Their indicators will be recorded during a routine visit to the doctor at the baseline, after 12 and 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive non-pharmacological program intervention | Experimental | The experimental group receives usual diabetes care plus 24 weeks of the comprehensive non-pharmacological program intervention. |
|
| Usual diabetes care | No Intervention | This group is control, the patients receive usual diabetes care routines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Non-pharmacological Treatment Program | Combination Product | dietary supplement, specific type of exercise, self-management education |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Glycosylated Hemoglobin at 6 months | HbA1c value | at baseline and at 24-week postrandomization |
| Change from Baseline Body Mass Index at 6 months | BMI | at baseline and at 24-week postrandomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Blood Pressure at 6 months | Systolic and diastolic blood pressure at the brachial artery | at baseline and at 24-week postrandomization |
| Change from Baseline Lipid Profiles at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viktoriya Li, PhD | Contact | +77785568055 | liviktoriya0509@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Viktoriya Li, PhD | Astana Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Kazakhstan Marat Ospanov Medical University | Active, not recruiting | Aktobe | Aktobe | 030000 | Kazakhstan | |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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prospective, single-center
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Total Triglyceride, Total Cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL)
| at baseline and at 24-week postrandomization |
| Change from Baseline Homeostasis ModelAssessment of Insulin Resistance at 6 months (HOMA-IR) | Homeostasis ModelAssessment of Insulin Resistance | at baseline and at 24-week postrandomization |
| Astana Medical University |
| Recruiting |
| Astana |
| 010000 |
| Kazakhstan |
|
| The Center for Preventive Medicine and Life Extension of Nur-Sultan | Recruiting | Astana | 010000 | Kazakhstan |
|
| National Medical Research Center for Endocrinology, Ministry of Health of the Russian Federation | Active, not recruiting | Moscow | 101000 | Russia |
| D004700 | Endocrine System Diseases |