Type 2 Diabetes
Conditions
Keywords
type 2 diabetes mellitus, non-pharmacological treatment, lifestyle intervention, structured program
Brief summary
Evaluation of the effectiveness of comprehensive non-pharmacological treatment on metabolic disorders in type 2 diabetic patients
Detailed description
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.
Interventions
COMBINATION_PRODUCTComprehensive Non-pharmacological Treatment Program
dietary supplement, specific type of exercise, self-management education
Sponsors
Astana Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
prospective, single-center
Eligibility
Sex/Gender
ALL
Age
45 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Glycosylated Hemoglobin at 6 months | at baseline and at 24-week postrandomization | HbA1c value |
| Change from Baseline Body Mass Index at 6 months | at baseline and at 24-week postrandomization | BMI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Blood Pressure at 6 months | at baseline and at 24-week postrandomization | Systolic and diastolic blood pressure at the brachial artery |
| Change from Baseline Lipid Profiles at 6 months | at baseline and at 24-week postrandomization | Total Triglyceride, Total Cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) |
| Change from Baseline Homeostasis ModelAssessment of Insulin Resistance at 6 months (HOMA-IR) | at baseline and at 24-week postrandomization | Homeostasis ModelAssessment of Insulin Resistance |
Countries
Kazakhstan, Russia
Contacts
Primary ContactViktoriya Li, PhD
Outcome results
None listed