Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus (T2DM)

Interventions: Behavioral: Lifestyle intervention

Registration Number: NCT02670928

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 130

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group of patients	Lifestyle intervention	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.
Active group of patients	Lifestyle intervention	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12	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

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12	Basline, Month 12	Analysis of percentage changes in Fasting Plasma Glucose (FPG, mmol/l) levels compared to Baseline at 12 months of follow-up
Percentage Change From Baseline in Cholesterol at Month 12	Baseline, Month 12	Analysis of percentage changes in lipid profile (cholesterol, mmol/l) compared to Baseline at 12 months of follow-up
Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12	Month 12	Changes of Baseline in Body Mass Index (BMI) levels expressed in percents compared to Baseline at 12 months of follow-up
Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12	Baseline, Month 12	Analysis of percentage in lipid profile (LDL, mmol/l and HDL, mmol/l) compared to Baseline at 12 months of follow-up
Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12	Baseline, 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)
Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12	Baseline, 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
Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline	Baseline, Month 3, Month 6, Month 9, Month 12	Number (portion) of patients achieved weight loss by at least 5% in comparison with Baseline at 3, 6, 9 months of follow-up
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12	Baseline, Month 12	Analysis of percentage changes in Glycosylated hemoglobin (HbA1c, %) levels compared to Baseline at 12 months follow-up
Percentage Change From Baseline in Triglycerides at Month 12	Baseline, Month 12	Analysis of percentage in lipid profile (triglycerides, mmol/l) compared to Baseline at 12 months of follow-up