"The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients"
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Change from Baseline Body Mass Index at 6 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 59 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Comprehensive non-pharmacological program intervention
The experimental group receives usual diabetes care plus 24 weeks of the comprehensive non-pharmacological program intervention.
Intervention: Comprehensive Non-pharmacological Treatment Program (Combination Product)
Usual diabetes care
This group is control, the patients receive usual diabetes care routines.
Outcomes
Primary Outcomes
Change from Baseline Body Mass Index at 6 months
Time Frame: at baseline and at 24-week postrandomization
BMI
Change from Baseline Glycosylated Hemoglobin at 6 months
Time Frame: at baseline and at 24-week postrandomization
HbA1c value
Secondary Outcomes
- Change from Baseline Blood Pressure at 6 months(at baseline and at 24-week postrandomization)
- Change from Baseline Lipid Profiles at 6 months(at baseline and at 24-week postrandomization)
- Change from Baseline Homeostasis ModelAssessment of Insulin Resistance at 6 months (HOMA-IR)(at baseline and at 24-week postrandomization)
Investigators
Viktoriya Li
PhD, Head of Rehabilitation
Astana Medical University