NCT02670928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 12, 2019

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

1.7 years

First QC Date

January 13, 2016

Results QC Date

April 5, 2018

Last Update Submit

April 11, 2019

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Diabeteslifestyle changeweight managementcontrol of glycemic in HbA1C and FPG

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

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

    Baseline, Month 12

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

    Baseline, Month 3, Month 6, Month 9, Month 12

  • Percentage Change From Baseline in Cholesterol at Month 12

    Baseline, Month 12

  • Percentage Change From Baseline in Triglycerides at Month 12

    Baseline, Month 12

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

    Baseline, Month 12

  • +4 more secondary outcomes

Study Arms (2)

Active group of patients

ACTIVE COMPARATOR

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

Control group of patients

EXPERIMENTAL

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

Interventions

Lifestyle interventionBEHAVIORAL

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.

Active group of patientsControl group of patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

Kazan', 420012, Russia

Location

Novartis Investigative Site

Moscow, 117036, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2016

First Posted

February 2, 2016

Study Start

July 20, 2015

Primary Completion

April 6, 2017

Study Completion

April 6, 2017

Last Updated

April 12, 2019

Results First Posted

April 12, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

RU(2)