"The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change from Baseline Body Mass Index at 6 months
研究概览
简要总结
Evaluation of the effectiveness of comprehensive non-pharmacological treatment on metabolic disorders in type 2 diabetic patients
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Comprehensive non-pharmacological program intervention
The experimental group receives usual diabetes care plus 24 weeks of the comprehensive non-pharmacological program intervention.
干预措施: Comprehensive Non-pharmacological Treatment Program (Combination Product)
Usual diabetes care
This group is control, the patients receive usual diabetes care routines.
结局指标
主要结局
Change from Baseline Body Mass Index at 6 months
时间窗: at baseline and at 24-week postrandomization
BMI
Change from Baseline Glycosylated Hemoglobin at 6 months
时间窗: at baseline and at 24-week postrandomization
HbA1c value
次要结局
- 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)
研究者
Viktoriya Li
PhD, Head of Rehabilitation
Astana Medical University