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Completed

NCT Number: NCT02670928

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Kazan', Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

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 outcomes

  1. Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12

    Time frame: Baseline, 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 outcomes

  1. Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12

    Time frame: Baseline, 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

  2. Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline

    Time frame: Baseline, Month 3, Month 6, Month 9, Month 12

    Number (portion) of patients achieved weight loss by at least 5% in comparison with Baseline at 3, 6, 9 months of follow-up

  3. Percentage Change From Baseline in Cholesterol at Month 12

    Time frame: Baseline, Month 12

    Analysis of percentage changes in lipid profile (cholesterol, mmol/l) compared to Baseline at 12 months of follow-up

  4. Percentage Change From Baseline in Triglycerides at Month 12

    Time frame: Baseline, Month 12

    Analysis of percentage in lipid profile (triglycerides, mmol/l) compared to Baseline at 12 months of follow-up

  5. Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12

    Time frame: Baseline, Month 12

    Analysis of percentage in lipid profile (LDL, mmol/l and HDL, mmol/l) compared to Baseline at 12 months of follow-up

  6. Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12

    Time frame: Baseline, 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)

  7. Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12

    Time frame: Baseline, Month 12

    Analysis of percentage changes in Glycosylated hemoglobin (HbA1c, %) levels compared to Baseline at 12 months follow-up

  8. Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12

    Time frame: Basline, Month 12

    Analysis of percentage changes in Fasting Plasma Glucose (FPG, mmol/l) levels compared to Baseline at 12 months of follow-up

  9. Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12

    Time frame: Month 12

    Changes of Baseline in Body Mass Index (BMI) levels expressed in percents compared to Baseline at 12 months of follow-up

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2016
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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