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

A

Astana Medical University

Status

Unknown

Conditions

Type 2 Diabetes

Treatments

Combination Product: Comprehensive Non-pharmacological Treatment Program

Study type

Interventional

Funder types

Other

Identifiers

NCT04632823
AstanaMU-1

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

45 to 59 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Comprehensive non-pharmacological program intervention
Experimental group
Description:
The experimental group receives usual diabetes care plus 24 weeks of the comprehensive non-pharmacological program intervention.
Treatment:
Combination Product: Comprehensive Non-pharmacological Treatment Program
Usual diabetes care
No Intervention group
Description:
This group is control, the patients receive usual diabetes care routines.

Trial contacts and locations

4

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Central trial contact

Viktoriya Li, PhD

Data sourced from clinicaltrials.gov

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