Back to resultsInterventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.
Primary Purpose
Type 2 Diabetes Mellitus (T2DM)
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
About this trial
This is an interventional other trial for Type 2 Diabetes Mellitus (T2DM) focused on measuring Diabetes, lifestyle change, weight management, control of glycemic in HbA1C and FPG
Eligibility Criteria
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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Active group of patients
Control group of patients
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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)
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
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
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
Full Information
NCT ID
NCT02670928
First Posted
January 13, 2016
Last Updated
April 11, 2019
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02670928
Brief Title
Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.
Official Title
Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 20, 2015 (Actual)
Primary Completion Date
April 6, 2017 (Actual)
Study Completion Date
April 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus (T2DM)
Keywords
Diabetes, lifestyle change, weight management, control of glycemic in HbA1C and FPG
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active group of patients
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group of patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention 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.
Primary Outcome Measure Information:
Title
Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12
Description
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
Title
Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline
Description
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
Title
Percentage Change From Baseline in Cholesterol at Month 12
Description
Analysis of percentage changes in lipid profile (cholesterol, mmol/l) compared to Baseline at 12 months of follow-up
Time Frame
Baseline, Month 12
Title
Percentage Change From Baseline in Triglycerides at Month 12
Description
Analysis of percentage in lipid profile (triglycerides, mmol/l) compared to Baseline at 12 months of follow-up
Time Frame
Baseline, Month 12
Title
Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12
Description
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
Title
Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12
Description
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
Title
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12
Description
Analysis of percentage changes in Glycosylated hemoglobin (HbA1c, %) levels compared to Baseline at 12 months follow-up
Time Frame
Baseline, Month 12
Title
Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12
Description
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
Title
Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
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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.
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