Back to results"The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients"
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Comprehensive Non-pharmacological Treatment Program
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes mellitus, non-pharmacological treatment, lifestyle intervention, structured program
Eligibility Criteria
Inclusion Criteria:
- medically diagnosed with type 2 diabetes mellitus
- HbA1c result of ≤7.0% within the past 2 months
- body mass index (BMI) of ≥26 kg/m^2
- hypoglycemic therapy: metformin only
Exclusion Criteria:
- pregnancy
- the use of other hypoglycemic drugs
- the use of medication for weight loss
- cardiovascular diseases (heart attack or cardiac procedure within the past 3 months)
- had stroke or history of treatment for transient ischemic attacks in the past 3 months
- had chronic renal failure or were on dialysis
- any conditions that do not allow the patient to perform the complex of the proposed physical exercises
Sites / Locations
- West Kazakhstan Marat Ospanov Medical University
- Astana Medical UniversityRecruiting
- The Center for Preventive Medicine and Life Extension of Nur-SultanRecruiting
- National Medical Research Center for Endocrinology, Ministry of Health of the Russian Federation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Comprehensive non-pharmacological program intervention
Usual diabetes care
Arm Description
The experimental group receives usual diabetes care plus 24 weeks of the comprehensive non-pharmacological program intervention.
This group is control, the patients receive usual diabetes care routines.
Outcomes
Primary Outcome Measures
Change from Baseline Glycosylated Hemoglobin at 6 months
HbA1c value
Change from Baseline Body Mass Index at 6 months
BMI
Secondary Outcome Measures
Change from Baseline Blood Pressure at 6 months
Systolic and diastolic blood pressure at the brachial artery
Change from Baseline Lipid Profiles at 6 months
Total Triglyceride, Total Cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL)
Change from Baseline Homeostasis ModelAssessment of Insulin Resistance at 6 months (HOMA-IR)
Homeostasis ModelAssessment of Insulin Resistance
Full Information
NCT ID
NCT04632823
First Posted
November 9, 2020
Last Updated
November 16, 2020
Sponsor
Astana Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04632823
Brief Title
"The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients"
Official Title
"The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients"
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Astana Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluation of the effectiveness of comprehensive non-pharmacological treatment on metabolic disorders in type 2 diabetic patients
Detailed Description
Patients in the intervention group will participate in a comprehensive non-pharmacological treatment of type 2 diabetes, the main components are:
changing the meal plan (individual and group counseling, assistance in developing menus and determining the calorie intake, keeping a food diary)
individually dosed physical exercises using specific exercise program;
comprehensive training (course of interactive lessons, self-control training). The program included group sessions with a team of specialists: nutritionist, endocrinologist, physical therapy doctor and included 3 sessions per week for 24 weeks. Each visit included teaching patients in a group format and in an interactive form (classes with specialists alternated), performing physical exercises using the specific exercise program under the supervision of a physiotherapy physician, evaluating medical indicators, and a self-control diary.
Patients in the control group will not participate in group sessions, but they had the opportunity to receive non-pharmacological care provided in the framework of free outpatient care. Their indicators will be recorded during a routine visit to the doctor at the baseline, after 12 and 24 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes mellitus, non-pharmacological treatment, lifestyle intervention, structured program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, single-center
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Comprehensive non-pharmacological program intervention
Arm Type
Experimental
Arm Description
The experimental group receives usual diabetes care plus 24 weeks of the comprehensive non-pharmacological program intervention.
Arm Title
Usual diabetes care
Arm Type
No Intervention
Arm Description
This group is control, the patients receive usual diabetes care routines.
Intervention Type
Combination Product
Intervention Name(s)
Comprehensive Non-pharmacological Treatment Program
Intervention Description
dietary supplement, specific type of exercise, self-management education
Primary Outcome Measure Information:
Title
Change from Baseline Glycosylated Hemoglobin at 6 months
Description
HbA1c value
Time Frame
at baseline and at 24-week postrandomization
Title
Change from Baseline Body Mass Index at 6 months
Description
BMI
Time Frame
at baseline and at 24-week postrandomization
Secondary Outcome Measure Information:
Title
Change from Baseline Blood Pressure at 6 months
Description
Systolic and diastolic blood pressure at the brachial artery
Time Frame
at baseline and at 24-week postrandomization
Title
Change from Baseline Lipid Profiles at 6 months
Description
Total Triglyceride, Total Cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL)
Time Frame
at baseline and at 24-week postrandomization
Title
Change from Baseline Homeostasis ModelAssessment of Insulin Resistance at 6 months (HOMA-IR)
Description
Homeostasis ModelAssessment of Insulin Resistance
Time Frame
at baseline and at 24-week postrandomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
medically diagnosed with type 2 diabetes mellitus
HbA1c result of ≤7.0% within the past 2 months
body mass index (BMI) of ≥26 kg/m^2
hypoglycemic therapy: metformin only
Exclusion Criteria:
pregnancy
the use of other hypoglycemic drugs
the use of medication for weight loss
cardiovascular diseases (heart attack or cardiac procedure within the past 3 months)
had stroke or history of treatment for transient ischemic attacks in the past 3 months
had chronic renal failure or were on dialysis
any conditions that do not allow the patient to perform the complex of the proposed physical exercises
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Viktoriya Li, PhD
Phone
+77785568055
Email
liviktoriya0509@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viktoriya Li, PhD
Organizational Affiliation
Astana Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Kazakhstan Marat Ospanov Medical University
City
Aktobe
State/Province
Aktobe Region
ZIP/Postal Code
030000
Country
Kazakhstan
Individual Site Status
Active, not recruiting
Facility Name
Astana Medical University
City
Astana
ZIP/Postal Code
010000
Country
Kazakhstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yerbolat Dalenov, Professor
Phone
+77017694241
Email
dalenov.e@amu.kz
First Name & Middle Initial & Last Name & Degree
Anna Bazarova, Docent
Facility Name
The Center for Preventive Medicine and Life Extension of Nur-Sultan
City
Astana
ZIP/Postal Code
010000
Country
Kazakhstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viktoriya Li, PhD
Phone
+77785568055
Email
liviktoriya0509@gmail.com
Facility Name
National Medical Research Center for Endocrinology, Ministry of Health of the Russian Federation
City
Moscow
ZIP/Postal Code
101000
Country
Russian Federation
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
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"The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients"
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