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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Mellitus (T2DM)

Intervention / Treatment
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* Behavioral: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active group of patients<br>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. | Behavioral: Lifestyle intervention<br>* 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.<br>|
| Experimental: Control group of patients<br>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. | Behavioral: Lifestyle intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, lifestyle change, weight management, control of glycemic in HbA1C and FPG