The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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Evaluation of the effectiveness of comprehensive non-pharmacological treatment on metabolic disorders in type 2 diabetic patients

Detailed Description
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Patients in the intervention group will participate in a comprehensive non-pharmacological treatment of type 2 diabetes, the main components are: changing the meal plan (individual and group counseling, assistance in developing menus and determining the calorie intake, keeping a food diary) individually dosed physical exercises using specific exercise program; comprehensive training (course of interactive lessons, self-control training). The program included group sessions with a team of specialists: nutritionist, endocrinologist, physical therapy doctor and included 3 sessions per week for 24 weeks. Each visit included teaching patients in a group format and in an interactive form (classes with specialists alternated), performing physical exercises using the specific exercise program under the supervision of a physiotherapy physician, evaluating medical indicators, and a self-control diary. 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.

Official Title
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The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Combination Product: Comprehensive Non-pharmacological Treatment Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: medically diagnosed with type 2 diabetes mellitus HbA1c result of ≤7.0% within the past 2 months body mass index (BMI) of ≥26 kg/m^2 hypoglycemic therapy: metformin only Exclusion Criteria: pregnancy the use of other hypoglycemic drugs the use of medication for weight loss cardiovascular diseases (heart attack or cardiac procedure within the past 3 months) had stroke or history of treatment for transient ischemic attacks in the past 3 months had chronic renal failure or were on dialysis any conditions that do not allow the patient to perform the complex of the proposed physical exercises

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, single-center
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive non-pharmacological program intervention<br>The experimental group receives usual diabetes care plus 24 weeks of the comprehensive non-pharmacological program intervention. | Combination Product: Comprehensive Non-pharmacological Treatment Program<br>* dietary supplement, specific type of exercise, self-management education<br>|
| No Intervention: Usual diabetes care<br>This group is control, the patients receive usual diabetes care routines. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes mellitus, non-pharmacological treatment, lifestyle intervention, structured program