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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
130
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.
Novartis Investigative Site
Kazan', Russia
Novartis Investigative Site
Moscow, Russia
Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at 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
Time frame: Baseline, Month 12
Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12
Decrease in blood pressure value was defined as at least 5 millimeters mercury (mmHg) in systolic and diastolic values in comparison to Baseline
Time frame: Baseline, Month 12
Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline
Number (portion) of patients achieved weight loss by at least 5% in comparison with Baseline at 3, 6, 9 months of follow-up
Time frame: Baseline, Month 3, Month 6, Month 9, Month 12
Percentage Change From Baseline in Cholesterol at Month 12
Analysis of percentage changes in lipid profile (cholesterol, mmol/l) compared to Baseline at 12 months of follow-up
Time frame: Baseline, Month 12
Percentage Change From Baseline in Triglycerides at Month 12
Analysis of percentage in lipid profile (triglycerides, mmol/l) compared to Baseline at 12 months of follow-up
Time frame: Baseline, Month 12
Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12
Analysis of percentage in lipid profile (LDL, mmol/l and HDL, mmol/l) compared to Baseline at 12 months of follow-up
Time frame: Baseline, Month 12
Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12
Patients were asked 'When did blood sugar level decrease most recently?' and the responses were reported on a Change in Quality of Life (QoL) expressed in percents using the Novartis survey in hypoglycemia and scale of individual perception of PhA (Scale of Borg)
Time frame: Baseline, Month 12
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12
Analysis of percentage changes in Glycosylated hemoglobin (HbA1c, %) levels compared to Baseline at 12 months follow-up
Time frame: Baseline, Month 12
Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12
Analysis of percentage changes in Fasting Plasma Glucose (FPG, mmol/l) levels compared to Baseline at 12 months of follow-up
Time frame: Basline, Month 12
Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12
Changes of Baseline in Body Mass Index (BMI) levels expressed in percents compared to Baseline at 12 months of follow-up
Time frame: Month 12
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