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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02670928

Enrollment

130

Registered

2016-02-02

Start date

2015-07-20

Completion date

2017-04-06

Last updated

2019-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Diabetes, lifestyle change, weight management, control of glycemic in HbA1C and FPG

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.

Interventions

BEHAVIORALLifestyle intervention

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12	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

Measure	Time frame	Description
Percentage Change From Baseline in Triglycerides at Month 12	Baseline, Month 12	Analysis of percentage in lipid profile (triglycerides, mmol/l) compared to Baseline at 12 months of follow-up
Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12	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
Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline	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
Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12	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
Percentage Change From Baseline in Cholesterol at Month 12	Baseline, Month 12	Analysis of percentage changes in lipid profile (cholesterol, mmol/l) compared to Baseline at 12 months of follow-up
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12	Baseline, Month 12	Analysis of percentage changes in Glycosylated hemoglobin (HbA1c, %) levels compared to Baseline at 12 months follow-up
Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12	Basline, Month 12	Analysis of percentage changes in Fasting Plasma Glucose (FPG, mmol/l) levels compared to Baseline at 12 months of follow-up
Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12	Month 12	Changes of Baseline in Body Mass Index (BMI) levels expressed in percents compared to Baseline at 12 months of follow-up
Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12	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)

Countries

Russia

Participant flow

Recruitment details

This study was conducted in the following jurisdiction: Russia (2 centers).

Participants by arm

Arm	Count
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.	100
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.	30
Total	130

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	3	1
Overall Study	Lost to Follow-up	1	0
Overall Study	Miss 3 classes in a row in first 12 wks	2	0
Overall Study	Withdrawal by Subject	4	0

Baseline characteristics

Characteristic	Control Group of Patients	Total	Active Group of Patients
Age, Continuous	60.6 Years STANDARD_DEVIATION 8.9	56.0 Years STANDARD_DEVIATION 10.2	54.6 Years STANDARD_DEVIATION 10.2
Race/Ethnicity, Customized Caucasian	29 Participants	128 Participants	99 Participants
Race/Ethnicity, Customized Oriental	1 Participants	2 Participants	1 Participants
Sex: Female, Male Female	19 Participants	88 Participants	69 Participants
Sex: Female, Male Male	11 Participants	42 Participants	31 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 100	1 / 30
other Total, other adverse events	0 / 100	0 / 30
serious Total, serious adverse events	6 / 100	2 / 30

Outcome results

Primary

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

Time frame: Baseline, Month 12