"The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients"

Type 2 Diabetes Clinical Trial

Official title:

"The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04632823
• Other study ID #: AstanaMU-1
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: November 2020
• Source: Astana Medical University
• Contact: Viktoriya Li, PhD
• Phone: +77785568055
• Email: liviktoriya0509[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the effectiveness of comprehensive non-pharmacological treatment on metabolic disorders in type 2 diabetic patients

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Metabolic Diseases
• Type 2 Diabetes

Intervention

Combination Product:
• Comprehensive Non-pharmacological Treatment Program
dietary supplement, specific type of exercise, self-management education

Locations

Country	Name	City	State
Kazakhstan	West Kazakhstan Marat Ospanov Medical University	Aktobe	Aktobe Region
Kazakhstan	Astana Medical University	Astana
Kazakhstan	The Center for Preventive Medicine and Life Extension of Nur-Sultan	Astana
Russian Federation	National Medical Research Center for Endocrinology, Ministry of Health of the Russian Federation	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Astana Medical University

Countries where clinical trial is conducted

Kazakhstan,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Glycosylated Hemoglobin at 6 months	HbA1c value	at baseline and at 24-week postrandomization
Primary	Change from Baseline Body Mass Index at 6 months	BMI	at baseline and at 24-week postrandomization
Secondary	Change from Baseline Blood Pressure at 6 months	Systolic and diastolic blood pressure at the brachial artery	at baseline and at 24-week postrandomization
Secondary	Change from Baseline Lipid Profiles at 6 months	Total Triglyceride, Total Cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL)	at baseline and at 24-week postrandomization
Secondary	Change from Baseline Homeostasis ModelAssessment of Insulin Resistance at 6 months (HOMA-IR)	Homeostasis ModelAssessment of Insulin Resistance	at baseline and at 24-week postrandomization