Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12
研究概览
简要总结
This study was aimed to achieve of long-term weight loss in T2DM patients by use of comprehensive lifestyle changes program, providing patients with structured diet, exercise plan, group behavioral support and group education. Additionally the study was designed to establish reduction of the body weight leads to the improvement of glycemic and lipid metabolism, and also reducing blood pressure level. The study was also directed to show that lifestyle changes program in T2DM patients can lead to decreasing of hospitalization rate and healthcare consumption. In order to demonstrate a change from standard of care, data were to be collected from a parallel cohort from the same centers.
详细描述
Patients of active group were assigned to receive activities of the program for life style changes. Patients in control group were managed in frames of routine clinical practice. No any investigational drug therapy was used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent. Written informed consent must be obtained before any assessment is performed.
- •≥ 18 years
- •Type 2 diabetes
- •The Body Mass Index is from 28 to 40 kg/m^2
排除标准
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
- •Type 1 diabetes
- •Proliferative retinopathy
- •Renal impairment: serum creatinine >1.5 mg/dL, creatinine clearance < 40 ml/min and/or proteinuria
- •The lack of ability to perform the physical exercises due to the orthopedic or cardiovascular disorders
- •Chronic alcoholism, acute alcoholic intoxication
研究组 & 干预措施
Active group of patients
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
干预措施: Lifestyle intervention (Behavioral)
Control group of patients
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
干预措施: Lifestyle intervention (Behavioral)
结局指标
主要结局
Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12
时间窗: Baseline, Month 12
Number (portion) of patients in the active group and control group in whom the body weight decreased by at least 5% compared to Baseline values at 12 months of follow-up
次要结局
- Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12(Basline, Month 12)
- Percentage Change From Baseline in Cholesterol at Month 12(Baseline, Month 12)
- Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12(Month 12)
- Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12(Baseline, Month 12)
- Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12(Baseline, Month 12)
- Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12(Baseline, Month 12)
- Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline(Baseline, Month 3, Month 6, Month 9, Month 12)
- Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12(Baseline, Month 12)
- Percentage Change From Baseline in Triglycerides at Month 12(Baseline, Month 12)