Clinical trial NCT02670928: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Diabetes
lifestyle change
weight management
control of glycemic in HbA1C and FPG
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-02-02
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12
timeFrame: Baseline, Month 12
measure: Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline
timeFrame: Baseline, Month 3, Month 6, Month 9, Month 12
measure: Percentage Change From Baseline in Cholesterol at Month 12
timeFrame: Baseline, Month 12
measure: Percentage Change From Baseline in Triglycerides at Month 12
timeFrame: Baseline, Month 12
measure: Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12
timeFrame: Baseline, Month 12
measure: Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12
timeFrame: Baseline, Month 12
measure: Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12
timeFrame: Baseline, Month 12
measure: Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12
timeFrame: Basline, Month 12
measure: Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12
timeFrame: Month 12
Other outcomes:
Locations:
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: