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

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670928
• Other study ID #: CLAF237ARU05
• Status: Completed
• Phase: Phase 4
• Start date: July 20, 2015
• Est. completion date: April 6, 2017

Study information

• Verified date: April 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 6, 2017
• Est. primary completion date: April 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Intervention

Behavioral:
• Lifestyle intervention
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.

Locations

Country	Name	City	State
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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