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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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ClinicalTrials.gov Identifier: NCT02670928
Recruitment Status : Completed
First Posted : February 2, 2016
Results First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus (T2DM) Behavioral: Lifestyle intervention Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.
Actual Study Start Date : July 20, 2015
Actual Primary Completion Date : April 6, 2017
Actual Study Completion Date : April 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: Active group of patients
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.
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.

Experimental: Control group of patients
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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670928


Locations
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Russian Federation
Novartis Investigative Site
Kazan, Russian Federation, 420012
Novartis Investigative Site
Moscow, Russian Federation, 117036
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] July 29, 2015
Statistical Analysis Plan  [PDF] July 4, 2017

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02670928    
Other Study ID Numbers: CLAF237ARU05
First Posted: February 2, 2016    Key Record Dates
Results First Posted: April 12, 2019
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Diabetes
lifestyle change
weight management
control of glycemic in HbA1C and FPG
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases