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

Novartis

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Behavioral: Lifestyle intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT02670928

CLAF237ARU05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Active group of patients

Active Comparator group

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.

Treatment:

Behavioral: Lifestyle intervention

Control group of patients

Experimental group

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.

Treatment:

Behavioral: Lifestyle intervention