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

November 16, 2020 updated by: Viktoriya Li, Astana Medical University
Evaluation of the effectiveness of comprehensive non-pharmacological treatment on metabolic disorders in type 2 diabetic patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • Recruiting
        • Astana Medical University
        • Contact:
          • Yerbolat Dalenov, Professor
          • Phone Number: +77017694241
          • Email: dalenov.e@amu.kz
        • Sub-Investigator:
          • Anna Bazarova, Docent
      • Astana, Kazakhstan, 010000
        • Recruiting
        • The Center for Preventive Medicine and Life Extension of Nur-Sultan
        • Contact:
    • Aktobe Region
      • Aktobe, Aktobe Region, Kazakhstan, 030000
        • Active, not recruiting
        • West Kazakhstan Marat Ospanov Medical University
  • Russian Federation
      • Moscow, Russian Federation, 101000
        • Active, not recruiting
        • National Medical Research Center for Endocrinology, Ministry of Health of the Russian Federation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comprehensive non-pharmacological program intervention
The experimental group receives usual diabetes care plus 24 weeks of the comprehensive non-pharmacological program intervention.
Combination product: Comprehensive Non-pharmacological Treatment Program
dietary supplement, specific type of exercise, self-management education
No Intervention: Usual diabetes care
This group is control, the patients receive usual diabetes care routines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Glycosylated Hemoglobin at 6 months
Time Frame: at baseline and at 24-week postrandomization
HbA1c value
at baseline and at 24-week postrandomization
Change from Baseline Body Mass Index at 6 months
Time Frame: at baseline and at 24-week postrandomization
BMI
at baseline and at 24-week postrandomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Blood Pressure at 6 months
Time Frame: at baseline and at 24-week postrandomization
Systolic and diastolic blood pressure at the brachial artery
at baseline and at 24-week postrandomization
Change from Baseline Lipid Profiles at 6 months
Time Frame: at baseline and at 24-week postrandomization
Total Triglyceride, Total Cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL)
at baseline and at 24-week postrandomization
Change from Baseline Homeostasis ModelAssessment of Insulin Resistance at 6 months (HOMA-IR)
Time Frame: at baseline and at 24-week postrandomization
Homeostasis ModelAssessment of Insulin Resistance
at baseline and at 24-week postrandomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astana Medical University

Investigators

  • Principal Investigator: Viktoriya Li, PhD, Astana Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 17, 2020

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AstanaMU-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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